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

August 1, 2015 updated by: Marat Vladislavovich Ezhov (MV Ezhov, MD, PhD, DMSc), Russian Cardiology Research and Production Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Active Comparator: percutaneous coronary intervention
2. elective balloon angioplasty alone or stent implanation on the basement of drugs treatment
Procedure: percutaneous coronary intervention
elective percutaneous coronary balloon angioplasty and/or stenting
Active Comparator: coronary artery bypass grafting
elective surgery myocardial revascularisation on the basement of drugs treatment
Procedure: coronary artery bypass grafting
elective surgical myocardial revascularisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non-fatal myocardial infarction and cardiovascular death
Time Frame: up to 15 years
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
Time Frame: 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
up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Russian Cardiology Research and Production Center

Investigators

  • Principal Investigator: Marat V. Ezhov, PhD, DMSc, Russian Cardiology Research and Production Center
  • Study Chair: Sergei N. Pokrovsky, PhD, DSc, Russian Cardiology Research and Production Center
  • Study Chair: Valery V. Kukharchuk, PhD, DMSc, Russian Cardiology Research and Production Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1993

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

August 1, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 1, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01200406198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on percutaneous coronary intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe