Brief Title
Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry
Official Title
Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry
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 Type
Observational [Patient Registry]
Primary Outcome
Major Adverse Cardiovascular Events
Condition
Hypertrophic
Intervention
Patients with a cardiomyopathy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
1600
Start Date
February 8, 2018
Completion Date
February 2028
Primary Completion Date
February 2028
Eligibility Criteria
Inclusion Criteria:
- Ischemic
- Dilated
- Hypertrophic
- Restrictive cardiomyopathy.
Exclusion Criteria:
- Pregnant women
- Breastfeeding women
- Patients under legal protection
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Gilles BARONE-ROCHETTE, PI, 0033476766652, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03479580
Organization ID
38RC17.215
Secondary IDs
2017-A02064-49
Responsible Party
Sponsor
Study Sponsor
University Hospital, Grenoble
Collaborators
Clinique Belledonne
Study Sponsor
Gilles BARONE-ROCHETTE, PI, Principal Investigator, University Hospital, Grenoble
Verification Date
March 2018