Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry (3CRegistry)

Long-term prognostic value of macrovascular and microvascular coronary artery stenoses in each type of cardiomyopathy.

Study Overview

• Status: Recruiting
• Conditions: Hypertrophic; Ischemic; Restrictive Cardiomyopathy; Dilated Cardiomyopathies
• Intervention / Treatment: Other: Patients with a cardiomyopathy

Detailed Description

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
• Enrollment (Anticipated): 1600

Contacts and Locations

• Study Contact: Name: Clémence CHARLON; Phone Number: 0033476766652; Email: ccharlon@chu-grenoble.fr

Study Locations

• France
  • La Tronche, France, 38700
    • Recruiting
    • University Hospital Grenoble
    • Contact: Gilles BARONE-ROCHETTE, MD, PHD
    • Contact: Clémence CHARLON, ARC; Phone Number: 0033476766652; Email: ccharlon@chu-grenoble.fr
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a cardiomyopathy

Description

Inclusion Criteria:

• Ischemic
• Dilated
• Hypertrophic
• Restrictive cardiomyopathy.

Exclusion Criteria:

• Pregnant women
• Breastfeeding women
• Patients under legal protection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events	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	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Groupe Hospitalier Mutualiste de Grenoble; Centre Hospitalier Annecy Genevois; Centre Hospitalier Metropole Savoie; Clinique Belledonne
• Investigators: Principal Investigator: Gilles BARONE-ROCHETTE, PI, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2018
• Primary Completion (ANTICIPATED): February 1, 2028
• Study Completion (ANTICIPATED): February 1, 2028

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (ACTUAL): March 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Prognosis; Coronary artery disease; Atherosclerosis; Cardiomyopathy; Myocardial ischemia; Multimodal imaging; Coronary microvascular disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiomyopathies; Cardiomyopathy, Dilated; Microvascular Angina; Cardiomyopathy, Restrictive
• Other Study ID Numbers: 38RC17.215; 2017-A02064-49 (OTHER: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No