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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Coronary Disease
• Interventions: Procedure: percutaneous coronary intervention; Procedure: coronary artery bypass grafting

• Registration Number: NCT02515747
• Lead Sponsor: Russian Cardiology Research and Production Center

Brief Summary

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

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.

Study Timeline

• Study Start: 1993-01
• Primary Completion: 2006-09
• Study Completion: 2014-01
• Study First Submitted: 2015-05-08
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-01
• Last Update Submitted: 2015-08-01
• Study First Posted: 2015-08-05
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous coronary intervention	percutaneous coronary intervention	2. elective balloon angioplasty alone or stent implanation on the basement of drugs treatment
coronary artery bypass grafting	coronary artery bypass grafting	elective surgery myocardial revascularisation on the basement of drugs treatment

Primary Outcome Measures

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

Secondary Outcome Measures

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