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Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry (3CRegistry)

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ClinicalTrials.gov Identifier: NCT03479580
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 11, 2018
Sponsor:
Collaborators:
Clinique Belledonne
Groupe Hospitalier Mutualiste de Grenoble
Centre Hospitalier Annecy Genevois
Centre Hospitalier Metropole Savoie
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment
Hypertrophic Ischemic Restrictive Cardiomyopathy Dilated Cardiomyopathies Other: Patients with a 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : February 2028
Estimated Study Completion Date : February 2028



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


Primary Outcome Measures :
  1. Major Adverse Cardiovascular Events [ Time Frame: 5 years ]
    Composite outcome = rate of cardiovascular death, non-fatal myocardial infarction, need for myocardial revascularization by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) > 3 months after enrollment. During follow up



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female and Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a cardiomyopathy
Criteria

Inclusion Criteria:

  • Ischemic
  • Dilated
  • Hypertrophic
  • Restrictive cardiomyopathy.

Exclusion Criteria:

  • Pregnant women
  • Breastfeeding women
  • Patients under legal protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479580


Contacts
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Contact: Clémence CHARLON 0033476766652 ccharlon@chu-grenoble.fr

Locations
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France
University Hospital Grenoble Recruiting
La Tronche, France, 38700
Contact: Gilles BARONE-ROCHETTE, MD, PHD         
Contact: Clémence CHARLON, ARC    0033476766652    ccharlon@chu-grenoble.fr   
Sub-Investigator: Matthieu CHACORNAC, MD         
Sub-Investigator: Loïc BELLE, MD         
Sub-Investigator: Vincent DESCOTES GENON, MD         
Sub-Investigator: Arnaud FLUTTAZ, MD         
Sub-Investigator: Damien GUIJARRO, MD         
Sub-Investigator: Benjamin FAURIE, MD         
Sub-Investigator: Jacques MONSEGU, MD         
Sub-Investigator: Benoit BERTHOUD, MD         
Sub-Investigator: Franck BARBOU, MD         
Sub-Investigator: Gérald VANZETTO, MD, PhD         
Sub-Investigator: Muriel SALVAT, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Clinique Belledonne
Groupe Hospitalier Mutualiste de Grenoble
Centre Hospitalier Annecy Genevois
Centre Hospitalier Metropole Savoie
Investigators
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Principal Investigator: Gilles BARONE-ROCHETTE, PI University Hospital, Grenoble

Additional Information:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03479580     History of Changes
Other Study ID Numbers: 38RC17.215
2017-A02064-49 ( Other Identifier: ID RCB )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Cardiomyopathy
Multimodal imaging
Coronary artery disease
Coronary microvascular disease
Prognosis
Atherosclerosis
Myocardial ischemia
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Cardiomyopathy, Restrictive
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiomegaly