Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

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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