Refractory Angina Clinical Trial
Official title:
Clinical Outcomes, Perfusion and Vascular Function in Patients With Refractory Angina and Raised Lipoprotein (a), Treated With Lipoprotein Apheresis
NCT number | NCT01796912 |
Other study ID # | 1880 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2013 |
Est. completion date | November 2015 |
Verified date | October 2019 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with refractory angina for more than three months. - Two or more episodes of angina per week. - Previous history of myocardial infarction, coronary artery bypass graft (CABG) surgery,percutaneous coronary intervention (PCI) or any combination of the above. - Prescribed optimal medical therapy. - Hypercholesterolaemia with an elevated Lp(a) > 50mg/dL and an LDL-cholesterol less than 4.0mmol/L despite optimal lipid lowering drug therapy. Exclusion Criteria: - Patients with poor calibre veins for cannulation. - Patients with any other chronic systemic illness such as liver or renal failure, neoplastic disease, overt cardiac failure, unstable coronary artery disease, coronary revascularisation or a myocardial infarction within the previous eight weeks. - Pregnancy, untreated diabetes mellitus, untreated arterial hypertension, and those with general contraindications to undergoing Cardiovascular magnetic resonance imaging or contraindications to adenosine. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Brompton and Harefield NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | National Institute for Health Research, United Kingdom |
United Kingdom,
Khan TZ, Hsu LY, Arai AE, Rhodes S, Pottle A, Wage R, Banya W, Gatehouse PD, Giri S, Collins P, Pennell DJ, Barbir M. Apheresis as novel treatment for refractory angina with raised lipoprotein(a): a randomized controlled cross-over trial. Eur Heart J. 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Quantitative Myocardial Perfusion Measured by Stress/Rest Cardiovascular Magnetic Resonance Imaging | 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 |
3 months | |
Secondary | Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging | Changes from baseline to 3 months | 3 months | |
Secondary | Change in Endothelial Vascular Function | EndoPat LnRHI - natural logarithm of reactive hyperaemia index. Increase - better outcome | Within 7 days before and after 3 months of weekly lipoprotein apheresis | |
Secondary | Change in Seattle Angina Questionnaire Score | SAQ—Angina stability, increase means improvement. 0-100 scale, Higher score means improvements | 3 months | |
Secondary | Change in SF-36 Quality of Life Score | Quality of Life score following, 0-100 score, high score improve quality of life | 3 months | |
Secondary | Change in Exercise Capacity Determined by Six Minute Walk Test | Six minute walk test, patient can walk longer distance means improvements | 3 months | |
Secondary | Changes in Markers of Thrombogenesis | Thrombogenesis, Reduce value is better to the patients | 3 months |
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