CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D014652: Vascular Diseases NIH

(Synonyms: Vascular Disea, Vascular Disease, Vascular Diseases)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)


Name (Synonyms) Correlation
drug9 0.9% saline Wiki 0.58
drug2417 Remote Photoplethysmography (rPPG) vital sign acquisition Wiki 0.58
drug797 Crizanlizumab Wiki 0.58
drug869 Device used to record voice for screening Wiki 0.58
drug3313 isocaloric/isonutrigenous ONS Wiki 0.58
drug949 EHR-based Clinician Jumpstart Wiki 0.58
drug3393 oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants Wiki 0.58

Correlated MeSH Terms (17)


Name (Synonyms) Correlation
D016491 Peripheral Vascular Diseases NIH 0.41
D058729 Peripheral Arterial Disease NIH 0.33
D009362 Neoplasm Metastasis NIH 0.29
D008103 Liver Cirrhosis, NIH 0.29
D051437 Renal Insufficiency, NIH 0.26
D008175 Lung Neoplasms NIH 0.26
D007676 Kidney Failure, Chronic NIH 0.22
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.20
D006331 Heart Diseases NIH 0.20
D006333 Heart Failure NIH 0.19
D017563 Lung Diseases, Interstitial NIH 0.17
D002908 Chronic Disease NIH 0.17
D012120 Respiration Disorders NIH 0.15
D008171 Lung Diseases, NIH 0.14
D012140 Respiratory Tract Diseases NIH 0.12
D009369 Neoplasms, NIH 0.12
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (9)


Name (Synonyms) Correlation
HP:0001395 Hepatic fibrosis HPO 0.29
HP:0004950 Peripheral arterial stenosis HPO 0.26
HP:0000083 Renal insufficiency HPO 0.26
HP:0100526 Neoplasm of the lung HPO 0.26
HP:0006510 Chronic pulmonary obstruction HPO 0.20
HP:0001635 Congestive heart failure HPO 0.19
HP:0006515 Interstitial pneumonitis HPO 0.17
HP:0002088 Abnormal lung morphology HPO 0.14
HP:0002664 Neoplasm HPO 0.12

There are 3 clinical trials

Clinical Trials


1 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 Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failure,Congestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart
MeSH: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 Neoplasms
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

2 Crizanlizumab for Treating COVID-19 Vasculopathy

The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.

NCT04435184 COVID-19 Drug: Crizanlizumab Other: 0.9% saline
MeSH:Vascular Diseases

Primary Outcomes

Description: Level of soluble P-selectin in ng/ml.

Measure: Soluble P-selectin level

Time: Day 7 after randomization

Secondary Outcomes

Description: Level of soluble P-selectin in ng/ml.

Measure: Soluble P-selectin level

Time: Day 14 after randomization

Description: Level of D-dimer in mg/L.

Measure: D-dimer level

Time: Day 7 after randomization

Description: Level of D-dimer in mg/L.

Measure: D-dimer level

Time: Day 14 after randomization

Description: Level of VWF antigen (percentage).

Measure: VWF level

Time: Day 7 after randomization

Description: Level of VWF antigen in (percentage).

Measure: VWF level

Time: Day 14 after randomization

Description: Level of C-reactive protein (CRP) in mg/dL.

Measure: CRP level

Time: Day 7 after randomization

Description: Level of C-reactive protein (CRP) in mg/dL.

Measure: CRP level

Time: Day 14 after randomization

Description: Change in the clinical status over 14 days as measured by an ordinal scale that is the first assessment of the clinical status on a given study day. The scale is as follows: 0 = Uninfected; no viral RNA detected = Ambulatory; asymptomatic; viral RNA detected = Ambulatory; symptomatic; independent = Ambulatory; symptomatic; assistance needed = Hospitalized; no oxygen therapy = Hospitalized; oxygen by mask or nasal prongs = Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow = Hospitalized; intubation and mechanical ventilation, partial pressure of oxygen / fraction of inspired oxygen (pO2/FIO2) ≥ 150 or oxygen saturation / FIO2 (SpO2/FIO2) ≥ 200 = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 < 150 or SpO2/FIO2 < 200 or vasopressors = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 < 150 or SpO2/FIO2 < 200 and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) = Dead

Measure: Change in clinical status as assessed by the World Health Organization (WHO) Ordinal Scale for COVID-19 Trials

Time: Daily up to day 14 after randomization

Description: Time (days) to hospital discharge

Measure: Time to hospital discharge

Time: Up to 30 days after randomization

Description: Safety of crizanlizumab will by assessed by adverse events, serious adverse events, and suspected unexpected serious adverse reactions.

Measure: Safety of Crizanlizumab as assessed by adverse events

Time: Up to day 14 after randomization

3 Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.

Contactless and widely available health monitoring technologies are of growing interest in the context of the worldwide COVID-19 pandemic. Remote photoplethysmography (rPPG) is a well-studied technology that interprets variations in skin colour related to blood flow which, when analysed with complex mathematical algorithm, generates vital sign readings. This technology has been refined and embedded in a smartphone app designed to acquire heart rate, respiratory rate and oxygen saturation using a front-facing smartphone camera. Preliminary data comparing the accuracy of smartphone rPPG readings with conventional vital sign monitor readings are promising; however, less than 5% of the population studied in the app development phase had oxygen saturation levels below 95% making it impossible to ensure reliability in these populations. The goal of this study is to compare readings acquired using this rPPG app with the readings from hospital grade, Health Canada approved vital signs monitors used in healthcare settings with a focus on subject with low oxygen saturations. We will also study other sociodemographic and clinical features that may influence the accuracy of the readings. This will be achieved by recruiting consenting adults presenting to care in acute care settings and a designated COVID outpatient clinic. Vital signs will be acquired using the rPPG app and conventional hospital vital sign monitors simultaneously. Readings will be repeated within 2-5 minutes when time permits. Statistical analysis will be performed to analyze the findings and determine the accuracy and precision of the rPPG app readings. It is expected that the vital sign readings acquired with the rPPG app will be almost identical to those acquired using hospital-grade monitors for all subjects regardless of age, gender, skin colour, COVID status and relevant comorbidities.

NCT04489407 Coronavirus Cardiac Disease Respiratory Disease Vascular Diseases Device: Remote Photoplethysmography (rPPG) vital sign acquisition
MeSH:Coronavirus Infections Respiration Disorders Vascular Diseases Heart Diseases Respiratory Tract Diseases

Primary Outcomes

Description: Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.

Measure: Accuracy of rPPG heart rate

Time: immediate; paired reading

Description: Accuracy of rPPG oxygen saturation compared to conventional vital sign monitor oxygen saturation readings. Comparison of discrepancy within each paired reading set.

Measure: Accuracy of rPPG oxygen saturation

Time: immediate; paired reading

Description: Accuracy of rPPG respiratory rate compared to manual counting of respiratory rate over 60 seconds. Comparison of discrepancy within each paired reading set.

Measure: Accuracy of rPPG respiratory rate

Time: immediate; paired reading

Secondary Outcomes

Description: Comparison of rPPG heart rate results obtained on a given patient on serial readings within 2 minutes of each other.

Measure: Reproducibility of rPPG heart rate readings

Time: 2-5 minutes

Description: Comparison of rPPG oxygen saturation results obtained on a given patient on serial readings within 2 minutes of each other.

Measure: Reproducibility of rPPG oxygen saturation readings

Time: 2-5 minutes

Description: Comparison of rPPG respiratory rate results obtained on a given patient on serial readings within 2 minutes of each other.

Measure: Reproducibility of rPPG respiratory rate readings

Time: 2-5 minutes

Other Outcomes

Description: Analysis of accuracy of rPPG vital sign readings when stratified by oxygen saturation per conventional monitors stratified as follows: 95-100%; 90-94%; 85-89%; Less than 85%

Measure: Accuracy of rPPG readings by oxygen saturation level

Time: immediate; stratified analysis

Description: Analysis of accuracy of rPPG vital sign readings when stratified by skin colour per the Fitzpatrick scale

Measure: Accuracy of rPPG readings by skin colour

Time: immediate; stratified analysis

Description: Analysis of accuracy of rPPG vital sign readings when stratified for gender

Measure: Accuracy of rPPG readings by gender

Time: immediate; stratified analysis

Description: Analysis of accuracy of rPPG vital sign readings when stratified by age group

Measure: Accuracy of rPPG readings by age

Time: immediate; stratified analysis

Description: Analysis of accuracy of rPPG vital sign readings when stratified for COVID, respiratory conditions, cardiac conditions and vascular conditions.

Measure: Accuracy of rPPG readings by comorbidity

Time: immediate; stratified analysis


HPO Nodes