Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

Ischemic Clinical Trial

— 3CRegistry  

Official title:

Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479580
• Other study ID #: 38RC17.215
• Secondary ID: 2017-A02064-49
• Status: Recruiting
• Start date: February 8, 2018
• Est. completion date: February 2028

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: Clémence CHARLON
• Phone: 0033476766652
• Email: ccharlon[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Ischemic

• Dilated

• Hypertrophic

• Restrictive cardiomyopathy.

Exclusion Criteria:

• Pregnant women

• Breastfeeding women

• Patients under legal protection

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Coronary Artery Disease
• Coronary Disease
• Dilated Cardiomyopathies
• Hypertrophic
• Ischemic
• Microvascular Angina
• Myocardial Ischemia
• Restrictive Cardiomyopathy

Intervention

Other:
• Patients with a cardiomyopathy
Prognostic value of coronary artery disease and microvascular disease in the different types of cardiomyopathies.

Locations

Country	Name	City	State
France	University Hospital Grenoble	La Tronche

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Centre Hospitalier Annecy Genevois, Centre Hospitalier Metropole Savoie, Clinique Belledonne, Groupe Hospitalier Mutualiste de Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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