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Rationale, design, and baseline characteristics of the CLARIFY registry of outpatients with stable coronary artery disease.

ABSTRACT: BACKGROUND:Despite major advances in prevention and treatment, coronary artery disease (CAD) remains the leading cause of death worldwide. Whereas many sources of data are available on the epidemiology of acute coronary syndromes, fewer datasets reflect the contemporary management and outcomes of stable CAD patients. HYPOTHESIS:A worldwide contemporary registry would improve our knowledge about stable CAD. The main objectives are to describe the demographics, clinical profile, contemporary management and outcomes of outpatients with stable CAD; to identify gaps between evidence and treatment; and to investigate long-term prognostic determinants. METHODS:CLARIFY (ProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease) is an ongoing international observational longitudinal registry. Stable CAD patients from 45 countries in Europe, Asia, America, Middle East, Australia and Africa were enrolled between November 2009 and June 2010. The inclusion criteria were previous myocardial infarction, evidence of coronary stenosis >50%, proven symptomatic myocardial ischemia or prior revascularization procedure. The main exclusion criteria were serious non-cardiovascular disease, conditions interfering with life expectancy or severe other cardiovascular disease (including advanced heart failure). Follow-up visits were planned annually for up to 5 years, interspersed with 6-month telephone calls. RESULTS:Of the 32,703 patients enrolled, most (77.6%) were male, age (mean ± SD) was 64.2 ± 10.5 years, and 71.0% were receiving treatment for hypertension; mean ± SD resting heart rate was 68.2 ± 10.6 bpm. Patients were enrolled based on a history of myocardial infarction >3 months earlier (57.7%), having at least one stenosis >50% on coronary angiography (61.1%), proven symptomatic myocardial ischemia on non-invasive testing (23.1%), or history of percutaneous coronary intervention or coronary artery bypass graft (69.8%). Baseline characteristics were similar across the four subgroups identified by the four inclusion criteria. CONCLUSION:CLARIFY will provide a useful resource for understanding the current epidemiology of stable CAD.

SUBMITTER: Sorbets E

PROVIDER: S-EPMC5697615 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Rationale, design, and baseline characteristics of the CLARIFY registry of outpatients with stable coronary artery disease.

Sorbets Emmanuel E Greenlaw Nicola N Ferrari Roberto R Ford Ian I Fox Kim M KM Tardif Jean-Claude JC Tendera Michal M Steg Philippe Gabriel PG

Clinical cardiology 20170531 10

<h4>Background</h4>Despite major advances in prevention and treatment, coronary artery disease (CAD) remains the leading cause of death worldwide. Whereas many sources of data are available on the epidemiology of acute coronary syndromes, fewer datasets reflect the contemporary management and outcomes of stable CAD patients.<h4>Hypothesis</h4>A worldwide contemporary registry would improve our knowledge about stable CAD. The main objectives are to describe the demographics, clinical profile, con ...[more]

PMID: 28561986

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Project description:BackgroundThe population of patients with established coronary artery disease (CAD) is growing because of an improvement in outcomes and survival from acute disease episodes. Nevertheless, these patients remain at high risk of cardiovascular events. Thus, CAD management is important in prevention of disease progression. The objective of this analysis was to describe disease management and clinical outcome of Austrian outpatients with stable CAD over 5 years by using data from the international CLARIFY registry.MethodsCLARIFY was an international prospective observational registry of outpatients with stable CAD, defined as prior myocardial infarction or revascularization (CABG or PCI), coronary stenosis of more than 50% by coronary angiography or chest pain with myocardial ischemia. We analyzed demographic characteristics, risk factors, treatments and clinical outcomes of 424 Austrian outpatients with established CAD who were enrolled between November 2009 and July 2010 and observed until September 2015.ResultsThe primary risk factors in Austrian outpatients with stable CAD were smoking (current smokers: 13.2%), overweight (77.1%), hypertension (78.5%), raised low-density lipoprotein (LDL) cholesterol plasma levels (81.4% ≥ 0.7 g/l or 1.8 mmol/l), elevated heart rate (≥70 bpm: 60.9% in patients with anginal symptoms) and poor physical activity (none or light activity: 63.4%). Patients received lipid-lowering drugs (predominantly statins), aspirin, beta-blockers and angiotensin-converting enzyme (ACE) inhibitors according to current recommendations. After 5 years a systolic blood pressure (SBP) < 140 mm Hg and diastolic blood pressure (DBP) < 90 mm Hg was reached in 58.5% of patients. Of the patients 70.4% had LDL cholesterol plasma levels below 1.0 g/l (2.6 mmol/l), 42.1% of smokers had stopped smoking, 42.9% of patients with anginal symptoms had a heart rate ≤60 bpm and 26.0% of diabetic patients had brought their HbA1c levels below 6.5%. Cardiovascular death, myocardial infarction or stroke occurred in 30 patients (7.1%), all-cause death in 25 cases (5.9%) and cardiovascular death in 15 cases (3.5%). Myocardial infarction was reported in 14 patients (fatal and non-fatal: 3.3%) and stroke in 8 patients (fatal and non-fatal: 1.9%), 39 patients (9.2%) underwent myocardial revascularization and 124 patients (29.2%) experienced cardiovascular hospitalization.ConclusionCharacteristics of Austrian outpatients with stable CAD corresponded to those of patients with CAD in other developed countries. Medical treatments following the recommendations of the European guidelines were prescribed in the majority of patients; however, recommended goals of life style interventions including a heart rate less than 60 bpm and general risk factor management were not achieved by a high proportion of patients. Heart rate control and life style changes remain unmet needs of cardiovascular care in Austria.

Project description:BackgroundCoronary artery disease (CAD) remains one of the leading causes of mortality and morbidity worldwide. As oxygen and nutrient supply to the myocardium significantly decrease during ischemic periods, important changes occur regarding myocardial intermediary energy metabolism. Metabolomics is an emerging field in systems biology, which quantifies metabolic changes in response to disease progression. This study aims to evaluate the diagnostic utility of plasma metabolomics-based biomarkers for determining the complexity and severity of CAD, as it is assessed via the SYNTAX score.MethodsCorlipid is a prospective, non-interventional cohort trial empowered to enroll 1065 patients with no previous coronary intervention history, who undergo coronary angiography in University Hospital AHEPA, Thessaloniki. Venous blood samples are collected before coronary angiography. State-of the-art analytical methods are performed to calculate the serum levels of novel biomarkers: ceramides, acyl-carnitines, fatty acids, and proteins such as galectin-3, adiponectin, and the ratio of apolipoprotein B/apolipoprotein A1. Furthermore, all patients will be categorized based on the indication for coronary angiography (acute coronary syndrome, chronic coronary syndrome, preoperative coronary angiography) and on the severity of CAD using the SYNTAX score. Follow-up of 12 months after enrollment will be performed to record the occurrence of major adverse cardiovascular events. A risk prediction algorithm will be developed by combining clinical characteristics with established and novel biomarkers to identify patients at high risk for complex CAD based on their metabolite signatures. The first patient was enrolled in July 2019 and completion of enrollment is expected until May 2021.DiscussionCorLipid is an ongoing trial aiming to investigate the correlation between metabolic profile and complexity of coronary artery disease in a cohort of patients undergoing coronary angiography with the potential to suggest a decision-making tool with high discriminative power for patients with CAD. To our knowledge, Corlipid is the first study aspiring to create an integrative metabolomic biomarkers-based algorithm by combining metabolites from multiple classes, involved in a wide range of pathways with well-established biochemical markers. Trial registration CorLipid trial registration: ClinicalTrials.gov number: NCT04580173. Registered 8 October 2020-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04580173 .

Project description:IntroductionThere are limited data on cerebrovascular events in patients with stable coronary artery disease. To study the risk of cerebrovascular event, the relative proportion of ischaemic stroke and intracranial haemorrhage, and their prognostic factors in stable coronary artery disease are investigated.Patients and methodsThe CORONOR registry prospectively recruited, between February 2010 and April 2011, 4184 unselected stable coronary artery disease outpatients. All events occurring during a five-year follow-up were adjudicated.ResultsNinety-six patients had an ischaemic stroke and 34 had an intracranial haemorrhage, reaching a cumulative incidence after five years of 3.2 (2.7-3.8)%. During the same period, 677 deaths and 170 myocardial infarctions (ST-elevation MI, n = 55; non-ST-elevation MI, n = 115) occurred. In elderly individuals, the number of cerebrovascular events was higher than that of myocardial infarctions and largely exceeded that of ST-elevation myocardial infarctions. Predictors of ischaemic stroke were: previous history of stroke (subhazard ratio (SHR)=3.16(1.95-5.14)), absence of statin therapy at inclusion (SHR = 2.45(1.47-4.10), increasing age (SHR = 1.45(1.16-1.82) per 10-year increase) and diabetes mellitus (SHR = 1.65(1.10-2.49)). Predictors of intracranial haemorrhage were: combination of vitamin K antagonists with an antiplatelet agent at inclusion (SHR = 5.41(2.49-11.75), single antiplatelet therapy as reference), and increasing age (SHR = 1.47(1.12-1.93) per 10-year increase).DiscussionIn stable coronary artery disease patients, the brain deserves attention. In patients at high risk of ischaemic stroke, secondary prevention could be intensified. Our results raise awareness of the hazard of the association of antiplatelet drugs with oral anticoagulants in stable coronary artery disease patients.ConclusionWhile improving the prevention of future vaso-occlusive events should be our ultimate goal in coronary artery disease patients, the net clinical benefit of our treatments should carefully be studied.

Dataset Information

Rationale, design, and baseline characteristics of the CLARIFY registry of outpatients with stable coronary artery disease.

Publications

Rationale, design, and baseline characteristics of the CLARIFY registry of outpatients with stable coronary artery disease.

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