Clinical trial NCT02515747: Prospective Russian Evaluation of Lp(a) Role in cardiovascUlar DiseasE
Official title: Role of Lipoprotein(a) Concentration and Apolipoprotein(a) Phenotype in Prediction of Coronary Events in General Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Cardiovascular Diseases
Keywords: Lipoprotein(a)
coronary artery bypass grafting (CABG)
apo(a)
prognosis
myocardial infarction
cardiovascular death
percutaneous coronary intervention (PCI)
Lead sponsor: Russian Cardiology Research and Production Center
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: non-fatal myocardial infarction and cardiovascular death
timeFrame: up to 15 years
Secondary outcomes:
measure: non-fatal myocardial infarction and cardiovascular death and myocardial revascularisation and hospitalization for recurrent or unstable angina
timeFrame: up to 15 years
Other outcomes:
Locations:
Study officials:
affiliation: Russian Cardiology Research and Production Center
name: Marat V. Ezhov, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Cardiology Research and Production Center
name: Sergei N. Pokrovsky, PhD, DSc
role: STUDY_CHAIR
affiliation: Russian Cardiology Research and Production Center
name: Valery V. Kukharchuk, PhD, DMSc
role: STUDY_CHAIR
References:
citation: Ezhov MV, Afanas'eva OI, Kambegova AA, Afanas'eva MI, Trukhacheva EP, Naumov VG, Pokrovskii SN. [The role of atherosclerosis risk factors in development of ischemic heart disease in young men]. Ter Arkh. 2009;81(5):50-4. Russian.
citation: Ezhov MV, Liakishev AA, Pokrovskii SN. [Lipoprotein (a) - an independent risk factor in atherosclerosis]. Ter Arkh. 2001;73(9):76-82. No abstract available. Russian.
citation: Pokrovsky SN, Ezhov MV, Il'ina LN, Afanasieva OI, Sinitsyn VY, Shiriaev AA, Akchurin RS. Association of lipoprotein(a) excess with early vein graft occlusions in middle-aged men undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2003 Oct;126(4):1071-5. doi: 10.1016/s0022-5223(03)00365-9.
citation: Ezhov MV, Safarova MC, Afanas'eva OI, Il'ina LN, Liakishev AA, Pokrovskii SN. [High level of lipoprotein (a) as a predictor of poor long-term prognosis after coronary artery bypass surgery]. Kardiologiia. 2011;51(1):18-22. Russian.
citation: Ezhov MV, Safarova MS, Afanasieva OI, Kukharchuk VV, Pokrovsky SN. Lipoprotein(a) level and apolipoprotein(a) phenotype as predictors of long-term cardiovascular outcomes after coronary artery bypass grafting. Atherosclerosis. 2014 Aug;235(2):477-82. doi: 10.1016/j.atherosclerosis.2014.05.944. Epub 2014 Jun 4.
citation: Britareva VV, Afanas'eva OI, Dobrovol'skii AB, Ezhov MV, Titaeva EV, Karpov IuA, Pokrovskii SN. [Lipoprotein(a) and Apo-A isoforms in patients with intermittent claudication]. Ter Arkh. 2002;74(12):49-52. Russian.
citation: Ezhov MV, Afanas'eva OI, Benevolenskaia GF, Savchenko AP, Balakhonova TV, Liakishev AA, Pokrovskii SN. [Association of lipoprotein(a) and apolipoprotein(a) phenotypes with coronary and carotid atherosclerosis in CHD men]. Ter Arkh. 2000;72(1):28-32. Russian.
citation: Ezhov MV, Afanas'ev OI, Benevolenskaia GF, Savchenko AP, Liakishev AA, Pokrovskii SN. [Lipoprotein(a) as a biochemical marker of coronary atherosclerosis]. Ter Arkh. 1997;69(9):31-4. Russian.
citation: Safarova MS, Trukhacheva EP, Ezhov MV, Afanas'eva OI, Afanas'eva MI, Tripoten' MI, Liakishev AA, Pokrovskii SN. [Pleiotropic effects of nicotinic acid therapy in men with coronary heart disease and elevated lipoprotein(a) levels]. Kardiologiia. 2011;51(5):9-16. Russian.