Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

NCT ID: NCT03479580

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-08

Study Completion Date

2028-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertrophic Ischemic Restrictive Cardiomyopathy Dilated Cardiomyopathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Patients with a cardiomyopathy

Prognostic value of coronary artery disease and microvascular disease in the different types of cardiomyopathies.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ischemic
* Dilated
* Hypertrophic
* Restrictive cardiomyopathy.

Exclusion Criteria

* Pregnant women
* Breastfeeding women
* Patients under legal protection
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Belledonne

UNKNOWN

Sponsor Role collaborator

Groupe Hospitalier Mutualiste de Grenoble

OTHER

Sponsor Role collaborator

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role collaborator

Centre Hospitalier Metropole Savoie

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles BARONE-ROCHETTE, PI

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital Grenoble

La Tronche, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Clémence CHARLON

Role: CONTACT

0033476766652

Facility Contacts

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Gilles BARONE-ROCHETTE, MD, PHD

Role: primary

Clémence CHARLON, ARC

Role: backup

0033476766652

Other Identifiers

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2017-A02064-49

Identifier Type: OTHER

Identifier Source: secondary_id

38RC17.215

Identifier Type: -

Identifier Source: org_study_id

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