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D058729: Peripheral Arterial Disease

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug3417 Temsirolimus Wiki 0.58
drug939 Covid-19 swab PCR test Wiki 0.58
drug1369 GM-CSF Wiki 0.58
Name (Synonyms) Correlation
drug1125 EHR-based Clinician Jumpstart Wiki 0.58
drug3028 Saline placebo Wiki 0.58
drug2505 Placebo Wiki 0.03

Correlated MeSH Terms (14)


Name (Synonyms) Correlation
D016491 Peripheral Vascular Diseases NIH 0.82
D014652 Vascular Diseases NIH 0.29
D009362 Neoplasm Metastasis NIH 0.29
Name (Synonyms) Correlation
D008103 Liver Cirrhosis, NIH 0.29
D051437 Renal Insufficiency, NIH 0.26
D007511 Ischemia NIH 0.24
D007676 Kidney Failure, Chronic NIH 0.22
D006333 Heart Failure NIH 0.18
D008175 Lung Neoplasms NIH 0.18
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.17
D017563 Lung Diseases, Interstitial NIH 0.17
D002908 Chronic Disease NIH 0.16
D008171 Lung Diseases, NIH 0.13
D009369 Neoplasms, NIH 0.11

Correlated HPO Terms (9)


Name (Synonyms) Correlation
HP:0004950 Peripheral arterial stenosis HPO 0.77
HP:0001395 Hepatic fibrosis HPO 0.29
HP:0000083 Renal insufficiency HPO 0.26
Name (Synonyms) Correlation
HP:0100526 Neoplasm of the lung HPO 0.22
HP:0001635 Congestive heart failure HPO 0.19
HP:0006510 Chronic pulmonary obstruction HPO 0.19
HP:0006515 Interstitial pneumonitis HPO 0.17
HP:0002088 Abnormal lung morphology HPO 0.13
HP:0002664 Neoplasm HPO 0.11

Clinical Trials

Navigate: Correlations   HPO

There are 3 clinical trials


1 Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease: The GPAD-3 Study

Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs, but can affect any arteries. Over time, plaque can harden and narrow the arteries which limits the flow of oxygen-rich blood to organs and other parts of the body. Blocked blood flow to the arteries can cause pain and numbness. The pain is usually worse with exercise and gets better with rest. PAD can raise the risk of getting an infection which could lead to tissue death and amputation. This study is investigating whether granulocyte-macrophage colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with PAD. GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells. Participants in the study will be randomly selected to receive GM-CSF or a placebo. After a four-week screening phase, participants will receive injections of GM-CSF or a placebo three times a week for three-weeks. Three months later, participants will again receive injections of GM-CSF or placebo three times a week for three-weeks. At six months, the study team will follow up to see if the group that received GM-CSF had more improvement than the group that received placebo.

NCT03304821
Conditions
  1. Peripheral Artery Disease (PAD)
Interventions
  1. Drug: GM-CSF
  2. Drug: Placebo
MeSH:Peripheral Arterial Disease Peripheral Vascular Diseases
HPO:Peripheral arterial stenosis

Primary Outcomes

Description: Participants will be walk up and down a 100-foot hallway for 6 minutes to cover the maximum distance possible. The distance, measured in feet, completed after 6 minutes will be recorded.

Measure: Change in 6-minute walk distance

Time: Baseline, Month 3, Month 6, Month 9

Secondary Outcomes

Description: Graded treadmill exercise testing will be performed using the Gardner protocol where the treadmill speed is kept at 2 mph and the grade starts at 0 and inclines by 2% every two minutes. The peak walking time (PWT) is the time until exercise is terminated because of severe claudication. Exercise testing will be performed twice and longest time will be used as the PWT for that study visit.

Measure: Change in Peak Walking Time (PWT)

Time: Baseline, Month 3, Month 6, Month 9

Description: The Walking Impairment Questionnaire (WIQ) domain of walking distance asks respondents to rate how difficult it is to walk around home, as well as distances of 50, 150, 300, 600, 900 and 1500 feet. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 28 with higher scores indicating increased ability to walk further distances.

Measure: Change in Walking Impairment Questionnaire (WIQ): Walking Distance Score

Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

Description: The Walking Impairment Questionnaire (WIQ) domain of walking speed asks respondents to rate how difficult it is to walk the distance of one block slowly, at an average speed, quickly, and running/jogging. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 16 with higher scores indicating increased ability to walk fast.

Measure: Change in Walking Impairment Questionnaire (WIQ): Walking Speed Score

Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

Description: The Walking Impairment Questionnaire (WIQ) domain of stair climbing asks respondents to rate how difficult it is to climb 1, 2, and 3 flights of stairs. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 12 with higher scores indicating better ability to climb stairs.

Measure: Change in Walking Impairment Questionnaire (WIQ): Stair Climbing Score

Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

Description: 36-item Short-Form Health Survey (SF-36) consists of eight scaled scores for the domains of: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Study participants respond to questions relating to their health and activity level by selecting from a variety of Likert scale and yes/no response options. Each scale is directly transformed into a 0-100 scale and lower scores indicate more disability (a score of 0 equates to maximum disability while a score of 100 indicates no disability).

Measure: Change in 36-item Short-Form Health Survey (SF-36) Score

Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

Description: Claudication onset time (COT) during the treadmill exercise will be recorded along with the peak walking time (PWT). The claudication onset time (COT) is the duration of exercise until onset of the participant's typical claudication. This is differentiated from the peak walking time (PWT) which is the time until exercise is terminated because of severe claudication. Graded treadmill exercise testing will be performed using the Gardner protocol where the treadmill speed is kept at 2 mph and the grade starts at 0 and inclines by 2% every two minutes.

Measure: Change in Claudication Onset Time (COT)

Time: Baseline, Month 3, Month 6, Month 9

Description: To obtain the ankle-brachial index (ABI), bilateral upper and lower extremity blood pressure cuffs are inflated about 30 millimeters of mercury (mmHg) above the systolic pressure. Doppler flow signals are used to detect the reappearing perfusion while reducing the cuff pressure. The results is expressed as a segmental/arm pressure ratio (ABI index). The highest pressure of the two arms will be used for calculating the ABI. The average ratio is about 1.0+/-0.10; an index of 0.90 or lower is considered abnormal. In patients with calcific, non-compressible arteries (certain diabetics) where ABI measurements are unreliable, a toe/ arm pressure index ratio will be performed, with a 2.5 cm cuff used on the great or second toes. A toe/arm index less than 0.65 is considered abnormal.

Measure: Change in Ankle-Brachial Index (ABI)

Time: Baseline, Month 3, Month 6, Month 9

Description: Foot transcutaneous oxygen tension (TcPO2) is a noninvasive way to measure peripheral arterial disease. TcPO2 is obtained with a monitor before exercise after the patients have been standing for three minutes and is monitored throughout exercise. Values are recorded at initial claudication distance, absolute claudication distance, and after recovery from exercise. A commonly used cut point is 60 millimeters of mercury (mmHg), with values below this indicating the presence of peripheral arterial disease.

Measure: Change in Foot Transcutaneous Oxygen Tension (TcPO2)

Time: Baseline, Month 3, Month 6, Month 9
2 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.

NCT04281784
Conditions
  1. Dementia
  2. Chronic Disease
  3. Neoplasm Metastasis
  4. Lung Neoplasm
  5. Pulmonary Disease, Chronic Obstructive
  6. Heart Failureļ¼ŒCongestive
  7. Liver Cirrhosis
  8. Kidney Failure, Chronic
  9. Lung Diseases, Interstitial
  10. Peripheral Vascular Disease
  11. Diabetes With End Organ Injury
  12. Palliative Care, Patient Care
  13. Health Care Quality, Access, and Evaluation
  14. Patient Care
  15. Inpatients
  16. Health Communication
  17. Patient Care Planning
Interventions
  1. Behavioral: EHR-based Clinician Jumpstart
MeSH:Neoplasms Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease
HPO:Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Left ventricular dysfunction Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure

Primary Outcomes

Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.

Measure: EHR documentation of Goals of Care discussions

Time: Assessed for the period between randomization and 30 days following randomization

Secondary Outcomes

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/ICU use: ICU admissions

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/ICU use: ICU length of stay

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/Hospital use: Hospital length of stay

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care: Hospital Readmissions 30 days

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care: ICU Readmissions 30 days

Time: Assessed for the period between randomization and 30 days following randomization

Description: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

Measure: Intensity of care: Healthcare costs

Time: 1 and 3 months after randomization

Description: From Washington State death certificates.

Measure: All-cause mortality at 1 year (safety outcome)

Time: 1 year after randomization

Other Outcomes

Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.

Measure: Key Implementation Factors

Time: 3 months after randomization
3 Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the Incidence of Ischemia-Driven Major Amputation, Clinically Driven Target Lesion Revascularization, and Clinically Relevant Target Lesion Occlusion After Revascularization of Lesions Below the Knee in Patients With Symptomatic Rutherford 3-5 Peripheral Artery Disease

A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.

NCT04433572
Conditions
  1. Peripheral Artery Disease
  2. Critical Limb Ischemia
Interventions
  1. Drug: Temsirolimus
  2. Drug: Saline placebo
MeSH:Peripheral Arterial Disease Ischemia
HPO:Peripheral arterial stenosis

Primary Outcomes

Description: Superiority of treatment vs. control group in the composite freedom from the following: Clinically Relevant Target Lesion Occlusion Clinically Driven Target Lesion Revascularization Ischemia-Driven Major Amputation of the Target Limb

Measure: Freedom from Cinical Relevant Target Lesion Failure

Time: 6 Months

Description: Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)

Measure: MALE + POD

Time: 30 Days

Secondary Outcomes

Description: Superiority of treatment vs. control group in the composite freedom from the following: Target Lesion Occlusion Clinically Driven Target Lesion Revascularization Ischemia-Driven Major Amputation of the target limb

Measure: Freedom from Target Lesion Failure

Time: 6 Months

Description: Death at the following time points

Measure: To determine non-inferiority in long-term mortality rate

Time: 12, 24, 36, 48, 60 months

Description: Composite of all-cause death or MALE of the target limb

Measure: To determine non-inferiority in freedom from all-cause death or major adverse limb event.

Time: 30 days, 6, 12 months

Description: Freedom from death and ischemia-driven major amputation of the target limb

Measure: To determine non-inferiority in amputation-free survival.

Time: 30 days, 6, 12, 24 months

Description: AEs/ARs will be categorized into one of the following: MALE of the target limb Non-MALE target limb SAE/SAR Other SAE/SAR Non-serious AE/AR AEs/ARs will further be classified as: Expected UADE SUSAR AEs/ARs will also be classified for relatedness (definitely, probably, possibly or not) to the following: Revascularization procedure Use of the Bullfrog device The study drug

Measure: Safety and tolerability will be assessed from overall rate of adverse events (subclassified as major, serious, non-serious, unanticipated, revascularization procedure-related, device-related and drug-related).

Time: 30 days, 6, 12, 24 months

Description: Taken individually: Ischemia-driven major amputation of the target limb CD-TLR Clinically relevant target lesion occlusion Any target lesion occlusion

Measure: Change of the individual components of the primary and secondary endpoints (ischemia-driven major amputation, clinically driven target lesion revascularization, clinically relevant target lesion occlusion or all target lesion occlusion)

Time: 6, 12, 24 months

Description: MALE of the target limb

Measure: Freedom from major adverse limb events

Time: 30 days, 6, 12, 24 months

Description: Total size of foot wounds on the target limb, percent and absolute change from baseline Status of foot wounds on the target limb Unassisted wound healing

Measure: Composite of the following wound healing measures

Time: 30 days, 6, 12 months

Description: Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)

Measure: Reduction in unplanned minor amputations

Time: 30 days, 6, 12 months

Description: Rutherford category and change from baseline

Measure: Rutherford score improvement

Time: 30 days, 6, 12, 24 months

Description: WIfI category and change from baseline

Measure: WIfI score improvement

Time: 30 days, 6, 12, 24 months

Description: Ankle-brachial index and change from baseline Toe-brachial index and change from baseline Toe pressure and change from baseline

Measure: Composite of hemodynamic improvement measures (ABI, TBI and toe pressure)

Time: 30 days, 6, 12, 24 months

Description: VascuQoL results and change from baseline

Measure: Patient reported quality of life benefits (VascuQoL)

Time: 30 days, 6, 12, 24 months

Description: WIQ results and change from baseline

Measure: Patient reported outcomes (walking impairment questionnaire) benefits

Time: 30 days, 6, 12, 24 months

Description: Primary patency rate Primary assisted patency rate

Measure: Primary and primary assisted patency rates

Time: 30 days, 6, 12, 24 months

Description: Primary sustained clinical improvement rate Secondary sustained clinical improvement rate

Measure: Primary and secondary sustained clinical improvement rates

Time: 30 days, 6, 12, 24 months

HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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