Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Lipoprotein Apheresis, then sham apheresis | Active Comparator | Three months of weekly lipoprotein apheresis, 1 month washout, then three month sham apheresis |
|
| First Sham Apheresis, then Lipoprotein Apheresis | Sham Comparator | Three months of weekly sham apheresis, 1 month washout, then three month lipoprotein Apheresis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipoprotein Apheresis | Other | Weekly lipoprotein apheresis for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging | Changes from baseline to 3 months | 3 months |
| Change in Endothelial Vascular Function | EndoPat LnRHI - natural logarithm of reactive hyperaemia index. Increase - better outcome |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dudley Pennell, MB BChir MA MD FRCP | Imperial College London | Principal Investigator |
| Mahmoud Barbir, MB BCh, FRCP | Royal Brompton and Harfield Hospital, Imperial College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton and Harefield NHS Foundation Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28453721 | Result | 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. 2017 May 21;38(20):1561-1569. doi: 10.1093/eurheartj/ehx178. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | First Lipoprotein Apheresis, Then Sham Apheresis | Three months of weekly lipoprotein apheresis, 1 month of washout then three month of sham apheresis |
| FG001 | First Sham Apheresis, Then Lipoprotein Apheresis | Three months of weekly sham apheresis, 1 month of washout then three months of weekly lipoprotein apheresis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participant | Participant were 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 then crossovered to the opposite study arm with the protocol repeated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | ratio | 3 months |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lipoprotein Apheresis | Three months of weekly lipoprotein apheresis | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dudley Pennell | Imperiwal College London | +44 (0)20 3811 6871 | d.pennell@imperial.ac.uk |
Not provided
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Apheresis | Other | Weekly sham (placebo) apheresis for 3 months |
|
| Within 7 days before and after 3 months of weekly lipoprotein apheresis |
| Change in Seattle Angina Questionnaire Score | SAQ-Angina stability, increase means improvement. 0-100 scale, Higher score means improvements | 3 months |
| Change in SF-36 Quality of Life Score | Quality of Life score following, 0-100 score, high score improve quality of life | 3 months |
| Change in Exercise Capacity Determined by Six Minute Walk Test | Six minute walk test, patient can walk longer distance means improvements | 3 months |
| Changes in Markers of Thrombogenesis | Thrombogenesis, Reduce value is better to the patients | 3 months |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging | Changes from baseline to 3 months | Posted | Median | Inter-Quartile Range | mm3 | 3 months |
|
|
|
|
| Secondary | Change in Endothelial Vascular Function | EndoPat LnRHI - natural logarithm of reactive hyperaemia index. Increase - better outcome | Posted | Mean | 95% Confidence Interval | index | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 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 | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
|
|
|
|
| Secondary | Change in Exercise Capacity Determined by Six Minute Walk Test | Six minute walk test, patient can walk longer distance means improvements | Posted | Median | Inter-Quartile Range | meter | 3 months |
|
|
|
|
| Secondary | Changes in Markers of Thrombogenesis | Thrombogenesis, Reduce value is better to the patients | Posted | Median | Inter-Quartile Range | seconds | 3 months |
|
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sham Apheresis | Three months of weekly sham apheresis | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |