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| Name | Class |
|---|---|
| Clinical Diagnostic Center MEDSI | UNKNOWN |
| Moscow State Government | UNKNOWN |
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To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy could affect atherosclerotic disease burden in coronary and carotid arteries of coronary heart disease patients with elevated Lp(a) levels.
Following the hypothesis that if Lp(a) excess has a pathogenic role in atherogenesis, then specific elimination of circulating Lp(a) should affect plaque growth and stability, we evaluated the efficacy of Lp(a) apheresis on changes in coronary plaque volume and composition and carotid intima-media thickness in patients with CHD on the background of optimal medical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific Lp(a) apheresis & Atorvastatin | Experimental | Specific Lp(a) apheresis was performed with "Lp(a) Lipopak" immunosorbent columns ("POCARD" Ltd., Moscow, Russia) with sheep polyclonal monospecific antibodies against human Lp(a)/apo(a) weekly during 18 months. On the background - standard medical therapy in accordance with the recommendations for secondary prevention of CHD. |
|
| Atorvastatin | No Intervention | Standard medical therapy in accordance with the recommendations for secondary prevention of CHD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific Lp(a) apheresis | Procedure | Specific Lp(a) apheresis procedures were carried out weekly with "Lp(a) Lipopak" columns (POCARD Ltd., Moscow, Russia) according to the standard protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Diameter Stenosis | The absolute change from baseline to 18 months in mean percent diameter stenosis, determined by quantitative coronary angiography (QCA) as the narrowest lesion in each segment and calculated as: ((reference diameter-minimal lumen diameter (MLD))/reference diameter)x100. | From Baseline to End of Study (Week 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean carotid intima-media thickness (IMT) | Change from baseline in mean carotid IMT, as measured by duplex ultrasonography of common carotid arteries after 9 and 18 months. | From Baseline to Week 36 (9 months) and to Week 72 (18 months) |
| Numbers of Coronary segments Showing Regression |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol (TC) Serum Level | Mean changes in TC level over the 18-month study period | From Baseline to Week 4, 36, 72 |
| Lipoprotein(a) (Lp(a)) serum levels | Mean changes in Lp(a) level over the 18-month study period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergei Pokrovsky, PhD, DSc | Russian Cardiology Research and Production Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian Cardiology Research and Production Center | Moscow | 121552 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23357149 | Result | Safarova MS, Ezhov MV, Afanasieva OI, Matchin YG, Atanesyan RV, Adamova IY, Utkina EA, Konovalov GA, Pokrovsky SN. Effect of specific lipoprotein(a) apheresis on coronary atherosclerosis regression assessed by quantitative coronary angiography. Atheroscler Suppl. 2013 Jan;14(1):93-9. doi: 10.1016/j.atherosclerosissup.2012.10.015. | |
| 29096833 |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003327 | Coronary Disease |
| D002340 | Carotid Artery Diseases |
| D003324 | Coronary Artery Disease |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D001054 | Apolipoproteins A |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001053 | Apolipoproteins |
| D008074 | Lipoproteins |
| D008055 | Lipids |
| D001059 |
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|
Clinically relevant regression or progression was defined as a change from baseline to follow up of ≥10% for percent diameter stenosis |
| From baseline to End of study (Week 72) |
| Number of Carotid Segments showing Regression | Carotid IMT progression criterion for the 18 months of treatment was considered as growth rate of 0.02 mm (0.015 mm/yr). No changes or reduction in carotid IMT ≥ 0,02 mm served as criterion of stabilization and regression of carotid atherosclerosis, respectively. | From Baseline to End of study (Week 72) |
| Change in total atheroma volume (TAV) from baseline to 18 months post-therapy | TAV at baseline - TAV at Week 72 assessed by intravascular ultrasound (IVUS) imaging of a targeted coronary artery | From Baseline to Week 72 |
| Change in absolute volumes of plaque components | Mean change in absolute volumes of plaque components: fibrotic, fibrofatty, necrotic core or dense calcium, assessed by radiofrequency intravascular ultrasonographic (IVUS) imaging at baseline and 18 months post-therapy | From Baseline to Week 72 |
| Change in relative amount of plaque components | Mean change in relative amounts of plaque components: fibrotic, fibrofatty, necrotic core or dense calcium, assessed by radiofrequency intravascular ultrasonographic (IVUS) imaging at baseline and 18 months post-therapy | From baseline to Week 72 |
| Numbers of Coronary Plaques Showing Regression | Regression was defined as decrease in TAV for all anatomically comparable cross sectional areas of targeted coronary artery from baseline of ≥ 0,1 mm cubed | From baseline to End of study (Week 72) |
| Acute change in Lp(a) level | Difference in Lp(a) concentration before and after specific Lp(a) apheresis procedure calculated as the mean of all measurements | Once a week over 72 week period of active treatment |
| Change in quality of life (QOL) | To evaluate the impact of the specific Lp(a) removal therapy on the quality of life using Seattle Angina Questionnaire (SAQ) and Exercise stress test as compared with standard guideline-driven medical therapy of CHD patients | from baseline to week 72 |
| From Baseline to Week 4, 36, 72 |
| Low-density lipoprotein cholesterol (LDL-C) serum Level | Mean changes in LDL-C level over the 18-month study period | From Baseline to Week 4, 36, 72 |
| Change in corrected LDL-C (LDL-C corr) Serum level | Since all included patients had high Lp(a) levels, to avoid overestimation of LDL-C fraction estimated LDL-C levels were corrected for cholesterol derived from Lp(a). Corrected LDL-C (LDL-C corr) was calculated using Dahlen's modification of the Friedewald formula: LDL-C corr = TC - (HDL-C) - (TG / 2.2) - (0.3 x Lp(a) / 38.7). For values in mmol/L, Lp(a) in mg/dL | From Baseline to Week 4, 36, 72 |
| Change in triglycerides (TG) serum Level | Mean changes in TG level over the 18-month study period | From Baseline to Week 4, 36, 72 |
| Change in high-density lipoprotein cholesterol (HDL-C) serum level | Mean changes in HDL-C level over the 18-month study period | From Baseline to Week 4, 36, 72 |
| Change in hemoglobin level | From Baseline to Week 4, 36, 72 |
| Change in creatinine level | From Baseline to Week 4, 36, 72 |
| Change in creatine kinase (CK) level | From Baseline to Week 4, 36, 72 |
| Change in alanine transaminase (ALT) level | From Baseline to Week 4, 36, 72 |
| Change in aspartate transaminase (AST) level | From Baseline to Week 4, 36, 72 |
| Pokrovsky SN, Afanasieva OI, Safarova MS, Balakhonova TV, Matchin YG, Adamova IYU, Konovalov GA, Ezhov MV. Specific Lp(a) apheresis: A tool to prove lipoprotein(a) atherogenicity. Atheroscler Suppl. 2017 Nov;30:166-173. doi: 10.1016/j.atherosclerosissup.2017.05.004. Epub 2017 May 31. |
| 27213629 | Derived | Pokrovsky SN, Afanasieva OI, Ezhov MV. Lipoprotein(a) apheresis. Curr Opin Lipidol. 2016 Aug;27(4):351-8. doi: 10.1097/MOL.0000000000000319. |
| 25936321 | Derived | Ezhov MV, Safarova MS, Afanasieva OI, Pogorelova OA, Tripoten MI, Adamova IY, Konovalov GA, Balakhonova TV, Pokrovsky SN. Specific Lipoprotein(a) apheresis attenuates progression of carotid intima-media thickness in coronary heart disease patients with high lipoprotein(a) levels. Atheroscler Suppl. 2015 May;18:163-9. doi: 10.1016/j.atherosclerosissup.2015.02.025. |
| D017202 |
| Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Apoproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |