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Recruiting NCT03479580

Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

Observational Hypertrophic Ischemic Restrictive Cardiomyopathy Dilated Cardiomyopathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patients with a cardiomyopathy.
Who it may be relevant to
Registry conditions: Hypertrophic, Ischemic, Restrictive Cardiomyopathy, Dilated Cardiomyopathies. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Major Adverse Cardiovascular Events [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Ischemic
  • Dilated
  • Hypertrophic
  • Restrictive cardiomyopathy.

Exclusion criteria

  • Pregnant women
  • Breastfeeding women
  • Patients under legal protection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • University Hospital Grenoble — La Tronche

Identifiers

NCT: NCT03479580 · 38RC17.215 · 2017-A02064-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗