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Completed

NCT Number: NCT02515747

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

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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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

elective percutaneous coronary balloon angioplasty and/or stenting

Coronary artery bypass grafting

Procedure

elective surgical myocardial revascularisation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Russian Cardiology Research and Production Center

Other

Registry information

Official study title

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

Acronym: PRELUDE

Important dates

Study start
1993
Primary completion
2006
Study completion
2014
First posted
Aug 5, 2015
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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