Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry (3CRegistry)
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|ClinicalTrials.gov Identifier: NCT03479580|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment|
|Hypertrophic Ischemic Restrictive Cardiomyopathy Dilated Cardiomyopathies||Other: Patients with a cardiomyopathy|
Coronary artery imaging techniques have taken a central role in the assessment of cardiovascular (CV) diagnosis over the past two decades. Many patients with a cardiomyopathy are also found to have a bystander coronary artery disease, not responsible for their cardiomyopathy. However, the prognostic value of those bystander coronary artery diseases is not known.
Also, new imaging techniques have been developed to assess coronary microvascular disease, but the prognostic value of these findings is not known.
In this study, the investigators evaluate the incidence and the prognosis of bystander coronary artery disease and microvascular disease in patients with ischemic, hypertrophic, dilated and restrictive cardiomyopathies in 5 French centers.
Coronary angiography, cardiac magnetic resonance (CMR), tomographic coronary artery angiography, single-photon emission computed tomography (SPECT), rest and stress trans-thoracic echocardiography (TTE) results will be recorded.
Macrovascular coronary artery disease is defined by :
- a stenosis > 50 % in coronary angiography confirmed with myocardial ischemia (SPECT, stress echocardiography),
- a stenosis > 70 % (50% if it is the left main coronary artery)
- or a stenosis 30-70 % with a fractional flow reserve (FFR) < 0.8 Microvascular disease is defined by an index of microvascular resistance (IMR) >23 or myocardial perfusion heterogeneity imaging (MPHI) > 4 using SPECT or CMR.
Major adverse cardiovascular events (MACE) will be assessed 1 year, 2 years and 5 years after enrollment.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1600 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry|
|Actual Study Start Date :||February 8, 2018|
|Estimated Primary Completion Date :||February 2028|
|Estimated Study Completion Date :||February 2028|
- Other: Patients with a cardiomyopathy
Prognostic value of coronary artery disease and microvascular disease in the different types of cardiomyopathies.
- Major Adverse Cardiovascular Events [ Time Frame: 5 years ]Composite outcome = rate of cardiovascular death, non-fatal myocardial infarction, need for myocardial revascularization by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) > 3 months after enrollment. During follow up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479580
|Contact: Clémence CHARLONemail@example.com|
|University Hospital Grenoble||Recruiting|
|La Tronche, France, 38700|
|Contact: Gilles BARONE-ROCHETTE, MD, PHD|
|Contact: Clémence CHARLON, ARC 0033476766652 firstname.lastname@example.org|
|Sub-Investigator: Matthieu CHACORNAC, MD|
|Sub-Investigator: Loïc BELLE, MD|
|Sub-Investigator: Vincent DESCOTES GENON, MD|
|Sub-Investigator: Arnaud FLUTTAZ, MD|
|Sub-Investigator: Damien GUIJARRO, MD|
|Sub-Investigator: Benjamin FAURIE, MD|
|Sub-Investigator: Jacques MONSEGU, MD|
|Sub-Investigator: Benoit BERTHOUD, MD|
|Sub-Investigator: Franck BARBOU, MD|
|Sub-Investigator: Gérald VANZETTO, MD, PhD|
|Sub-Investigator: Muriel SALVAT, MD|
|Principal Investigator:||Gilles BARONE-ROCHETTE, PI||University Hospital, Grenoble|