Clinical trial NCT03479580: Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry
Official title: Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic
Ischemic
Restrictive Cardiomyopathy
Dilated Cardiomyopathies
Keywords: Cardiomyopathy
Multimodal imaging
Coronary artery disease
Coronary microvascular disease
Prognosis
Atherosclerosis
Myocardial ischemia
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinique Belledonne
name: Groupe Hospitalier Mutualiste de Grenoble
name: Centre Hospitalier Annecy Genevois
name: Centre Hospitalier Metropole Savoie
First posted: 2018-03-27
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a cardiomyopathy

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.

Eligibility criteria: Inclusion Criteria:

* Ischemic
* Dilated
* Hypertrophic
* Restrictive cardiomyopathy.

Exclusion Criteria:

* Pregnant women
* Breastfeeding women
* Patients under legal protection

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Gilles BARONE-ROCHETTE, PI
role: PRINCIPAL_INVESTIGATOR
References: