Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

Recruiting

• Conditions: Hypertrophic; Dilated Cardiomyopathies; Restrictive Cardiomyopathy; Ischemic

• Registration Number: NCT03479580
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

• Study First Submitted: 2018-01-23
• Study Start: 2018-02-08
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19
• Primary Completion: 2028-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• Ischemic
• Dilated
• Hypertrophic
• Restrictive cardiomyopathy.

Exclusion Criteria

• Pregnant women
• Breastfeeding women
• Patients under legal protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 La Tronche, France