Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial): study protocol for a randomized controlled trial

Autor: Karsten Lenk, Madlen Uhlemann, Jennifer Adam, Holger Thiele, Sven Möbius-Winkler, Gerhard Schuler, Sandra Erbs, Matthias Gutberlet, Martin Grunze, Axel Linke, Volker Adams, Thomas Hilberg
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Cardiac Catheterization
Time Factors
medicine.medical_treatment
Medicine (miscellaneous)
Fractional flow reserve
Coronary Angiography
Severity of Illness Index
Coronary artery disease
Angina
Study Protocol
Germany
Pharmacology (medical)
Prospective Studies
Myocardial infarction
Stroke
Cardiac catheterization
lcsh:R5-920
Myocardial Perfusion Imaging
Atherogenesis
Collateral circulation
Coronary Vessels
Magnetic Resonance Imaging
Plaque
Atherosclerotic
Exercise Therapy
Fractional Flow Reserve
Myocardial
Treatment Outcome
medicine.anatomical_structure
Research Design
Cardiology
lcsh:Medicine (General)
medicine.medical_specialty
Pathophysiology
Exercise training
Coronary circulation
Oxygen Consumption
Coronary Circulation
Internal medicine
medicine
Humans
Ultrasonography
Interventional
business.industry
Coronary Stenosis
medicine.disease
Coronary collateral blood flow
Endothelium
Vascular
Interval training
business
Biomarkers
Zdroj: Trials, Vol 13, Iss 1, p 167 (2012)
Trials
ISSN: 1745-6215
Popis: Background Exercise training (ET) in addition to optimal medical therapy (OMT) in patients with stable coronary artery disease (CAD) has been demonstrated to be superior to percutaneous coronary interventions (PCI) with respect to the composite endpoint of death, myocardial infarction, stroke, revascularization and hospitalization due to worsening of angina. One mechanism leading to this superiority discussed in the literature is the increase in coronary collateral blood flow due to ET. Until now, data demonstrating the positive effect of ET on the collateral blood flow and the functional capacity of the coronary collateral circulation are still lacking. Methods/design The EXCITE trial is a three-armed randomized, prospective, single-center, open-label, controlled study enrolling 60 patients with stable CAD and at least one significant coronary stenosis (fractional flow reserve ≤0.75). The study is designed to compare the influence and efficacy of two different 4-week ET programs [high-intensity interval trainings (IT) versus moderate-intensity exercise training (MT) in addition to OMT] versus OMT only on collateral blood flow (CBF). The primary efficacy endpoint is the change of the CBF of the target vessel after 4 weeks as assessed by coronary catheterization with a pressure wire during interruption of the antegrade flow of the target vessel by balloon occlusion. Secondary endpoints include the change in plaque composition as assessed by intravascular ultrasound (IVUS) after 4 weeks, myocardial perfusion as analyzed in MRI after 4 weeks and 12 months, peak oxygen uptake (V02 peak), change in endothelial function and biomarkers after 4 weeks, 3, 6 and 12 months. The safety endpoint addresses major adverse cardiovascular events (death from cardiovascular cause, myocardial infarction, stroke, TIA, target vessel revascularization or hospitalization) after 12 months. Discussion The trial investigates whether ET for 4 weeks increases the CBF in patients with significant CAD compared to a sedentary control group. It also examines the impact of two intensities of ET on the CBF as well as the histological plaque composition. The trial started recruitment in June 2009 and will complete recruitment until June 2012. First results are expected in December 2012 (4-week follow-up), final results (12-month long-term secondary endpoint) in December 2013. Trial registration Clinical trial registration information-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01209637
Databáze: OpenAIRE
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