N/A
N=20
Lipoprotein Apheresis in Refractory Angina Study
Refractory Angina · Raised Lipoprotein(a)>50mg/dL or >500mg/L
Bottom Line
View on ClinicalTrials.gov: NCT01796912 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Changes in Quantitative Myocardial Perfusion Measured by Stress/Rest Cardiovascular Magnetic Resonance Imaging — 0.47; -0.16 ratio — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lipoprotein Apheresis (Other); Sham Apheresis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Quantitative Myocardial Perfusion Measured by Stress/Rest Cardiovascular Magnetic Resonance Imaging |
0.47; -0.16 | 0.001 sig |
| SECONDARY Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging |
-335; 127 | 0.001 sig |
| SECONDARY Change in Endothelial Vascular Function |
-0.05; -0.03 | 0.14 |
| SECONDARY Change in Seattle Angina Questionnaire Score |
17.5; -1.75 | 0.016 sig |
| SECONDARY Change in SF-36 Quality of Life Score |
7.5; -2 | 0.001 sig |
| SECONDARY Change in Exercise Capacity Determined by Six Minute Walk Test |
70.5; 3.5 | 0.001 sig |
| SECONDARY Changes in Markers of Thrombogenesis |
-355; 36 | 0.005 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01796912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.