SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01796912

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

Angina which is refractory to conventional medical therapy and revascularisation is challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to no effect on Lp(a) levels. 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

Lipoprotein Apheresis

Name: Sham Apheresis

Description: Weekly sham (placebo) apheresis for 3 months

Type: Other

Sham Apheresis


Primary Outcomes

Description: Investigators will determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging at baseline and after 3 months of weekly lipoprotein apheresis in patients with refractory angina and raised lipoprotein(a). This will be compared to quantitative perfusion before and after 3 months of sham apheresis.

Measure: Change in Quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging following 3 months weekly apheresis compared to baseline.

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

Secondary Outcomes

Measure: Change in Carotid Atherosclerosis/plaque burden determined by Cardiovascular Magnetic Resonance Imaging following 3 months weekly apheresis compared to baseline.

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

Measure: Change in Endothelial vascular function following 3 months weekly apheresis compared to baseline.

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

Measure: Change in Seattle Angina Questionnaire Score following 3 months weekly apheresis compared to baseline.

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

Measure: Change in SF-36 Quality of Life score following 3 months weekly apheresis compared to baseline.

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

Measure: Change in Exercise capacity determined by six minute walk test following 3 months weekly apheresis compared to baseline.

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

Measure: Changes in Markers of Thrombogenesis following 3 months weekly apheresis compared to baseline.

Time: Within 24 hours before and after 3 months of weekly lipoprotein apheresis

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:
Angina pectoris
Genes 31
MPL GATA4 GATA6 JAK2 TET2 LDLRAP1 CRELD1 PTPN22 APOB CTLA4 LIPC PRTN3 LCAT APOE ZMPSTE24 GLA PIGA LMNA PTEN IDUA HLA-DPA1 HLA-DPB1 LDLR ENPP1 ABCC6 ABCG5 ABCG8 NR2F2 CYP27A1 PCSK9 PMM2