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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-01-31

Study Completion Date

2014-01-31

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.

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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.

Conditions

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Coronary Disease Cardiovascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conservative treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

percutaneous coronary intervention

2\. elective balloon angioplasty alone or stent implanation on the basement of drugs treatment

Group Type ACTIVE_COMPARATOR

percutaneous coronary intervention

Intervention Type PROCEDURE

elective percutaneous coronary balloon angioplasty and/or stenting

coronary artery bypass grafting

elective surgery myocardial revascularisation on the basement of drugs treatment

Group Type ACTIVE_COMPARATOR

coronary artery bypass grafting

Intervention Type PROCEDURE

elective surgical myocardial revascularisation

Interventions

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percutaneous coronary intervention

elective percutaneous coronary balloon angioplasty and/or stenting

Intervention Type PROCEDURE

coronary artery bypass grafting

elective surgical myocardial revascularisation

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No