3CRegistry: Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Recruiting

CT.gov ID

NCT03479580

Collaborator

Clinique Belledonne (Other), Groupe Hospitalier Mutualiste de Grenoble (Other), Centre Hospitalier Annecy Genevois (Other), Centre Hospitalier Metropole Savoie (Other)

1,600

Enrollment

Location

119.8

Anticipated Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Ischemic Restrictive Cardiomyopathy Dilated Cardiomyopathies	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

Actual Study Start Date :

Feb 8, 2018

Anticipated Primary Completion Date :

Feb 1, 2028

Anticipated Study Completion Date :

Feb 1, 2028

Outcome Measures

Primary Outcome Measures

Major Adverse Cardiovascular Events [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