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Report for Clinical Trial NCT01796912

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Clinical Outcomes, Perfusion and Vascular Function in Patients With Refractory Angina and Raised Lipoprotein (a), Treated With Lipoprotein Apheresis

The goal of this study is to determine the impact of apheresis on clinical parameters and symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct a prospective, randomised controlled crossover study of 20 patients with refractory angina and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or sham apheresis weekly for three months with assessment of myocardial perfusion, carotid atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina symptoms and quality of life at the beginning and end of treatment. Patients will then crossover to the opposite study arm with the protocol repeated. The hypothesis is that the above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and Refractory Angina. Investigators will also test for the genotypic presence of apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to be associated with an increased level of Lp(a) and an increased risk of coronary disease.

NCT01796912 Refractory Angina Raised Lipoprotein(a) Raised Lipoprotein(a)> Raised Lipoprotein(a)>50mg/dL or Raised Lipoprotein(a)>50mg/dL or > Raised Lipoprotein(a)>50mg/dL or >500mg/L
MeSH:Angina Pectoris
HPO:Angina pectoris

2 Interventions

Name: Lipoprotein Apheresis

Description: Weekly lipoprotein apheresis for 3 months
Type: Other
Group Labels: 1

First Lipoprotein Apheresis, then sham apheresis

Name: Sham Apheresis

Description: Weekly sham (placebo) apheresis for 3 months
Type: Other
Group Labels: 1

First Sham Apheresis, then Lipoprotein Apheresis


Primary Outcomes

Description: Baseline compare to 3 month, changes presented Determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging. Increase means better outcome

Measure: Changes in Quantitative Myocardial Perfusion Measured by Stress/Rest Cardiovascular Magnetic Resonance Imaging

Time: 3 months

Secondary Outcomes

Description: Changes from baseline to 3 months

Measure: Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging

Time: 3 months

Description: EndoPat LnRHI - natural logarithm of reactive hyperaemia index. Increase - better outcome

Measure: Change in Endothelial Vascular Function

Time: Within 7 days before and after 3 months of weekly lipoprotein apheresis

Description: SAQ—Angina stability, increase means improvement. 0-100 scale, Higher score means improvements

Measure: Change in Seattle Angina Questionnaire Score

Time: 3 months

Description: Quality of Life score following, 0-100 score, high score improve quality of life

Measure: Change in SF-36 Quality of Life Score

Time: 3 months

Description: Six minute walk test, patient can walk longer distance means improvements

Measure: Change in Exercise Capacity Determined by Six Minute Walk Test

Time: 3 months

Description: Thrombogenesis, Reduce value is better to the patients

Measure: Changes in Markers of Thrombogenesis

Time: 3 months

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There are 2 SNPs

SNPs


1 rs10455872

Investigators will also test for the genotypic presence of apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to be associated with an increased level of Lp(a) and an increased risk of coronary disease.


2 rs3798220

Investigators will also test for the genotypic presence of apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to be associated with an increased level of Lp(a) and an increased risk of coronary disease.



HPO Nodes


HPO: