Prospective Russian Evaluation of Lp(a) Role in cardiovascUlar DiseasE

Study Overview
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Brief Summary
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The purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a) phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary disease patients divided on the basis of management strategy - medical, endovascular or open cardiac surgery.

Detailed Description
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Between January 1993 and September 2006, we enrolled 1400 consecutive patients from the Atherosclerosis Department with known Lp(a) levels and coronary heart disease (CHD) verified by angiography. In accordance with clinical condition and angiography data were assigned them into three parallel treatment arms and followed up to 15 years. This study was conducted according to the principles of the Declaration of Helsinki and the Institutional Ethics Committee.

Official Title
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Role of Lipoprotein(a) Concentration and Apolipoprotein(a) Phenotype in Prediction of Coronary Events in General Population

Conditions
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Coronary Disease, Cardiovascular Diseases

Intervention / Treatment
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* Procedure: percutaneous coronary intervention
* Procedure: coronary artery bypass grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable coronary heart disease verified by angiography Exclusion Criteria: acute coronary syndromes, acute infections, inflammatory disease within 3 months prior to inclusion, familial hypercholesterolemia, triglycerides>4.5 mmol/L, missing Lp(a) measurements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conservative treatment<br>Men and women with stable CHD verified by angiography from one center and allocated to three treatment arms in real-world practice: 1. conservative treatment with statins, antiaggregants, antianginal drugs in standard dosage | |
| Active Comparator: percutaneous coronary intervention<br>2. elective balloon angioplasty alone or stent implanation on the basement of drugs treatment | Procedure: percutaneous coronary intervention<br>* elective percutaneous coronary balloon angioplasty and/or stenting<br>|
| Active Comparator: coronary artery bypass grafting<br>elective surgery myocardial revascularisation on the basement of drugs treatment | Procedure: coronary artery bypass grafting<br>* elective surgical myocardial revascularisation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-fatal myocardial infarction and cardiovascular death | we took a composite primary outcome measure because anticipated a low number of hard-end-points in each treatment arm | up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-fatal myocardial infarction and cardiovascular death and myocardial revascularisation and hospitalization for recurrent or unstable angina | we chose a composite secondary outcome mesure as a standard for such type studies and to obtain a statistical difference between the groups | up to 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipoprotein(a), coronary artery bypass grafting (CABG), apo(a), prognosis, myocardial infarction, cardiovascular death, percutaneous coronary intervention (PCI)