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NCT Number: NCT03479580

Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

La Tronche, 38700, France

Location status: Recruiting

Location contact

Arnaud FLUTTAZ, MD

SUB_INVESTIGATOR

Benjamin FAURIE, MD

SUB_INVESTIGATOR

Benoit BERTHOUD, MD

SUB_INVESTIGATOR

Clémence CHARLON, ARC

CONTACT

[email protected]

0033476766652

Damien GUIJARRO, MD

SUB_INVESTIGATOR

Franck BARBOU, MD

SUB_INVESTIGATOR

Gilles BARONE-ROCHETTE, MD, PHD

CONTACT

Gérald VANZETTO, MD, PhD

SUB_INVESTIGATOR

Jacques MONSEGU, MD

SUB_INVESTIGATOR

Loïc BELLE, MD

SUB_INVESTIGATOR

Matthieu CHACORNAC, MD

SUB_INVESTIGATOR

Muriel SALVAT, MD

SUB_INVESTIGATOR

Vincent DESCOTES GENON, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic
  • Dilated
  • Hypertrophic
  • Restrictive cardiomyopathy.

Exclusion criteria

  • Pregnant women
  • Breastfeeding women
  • Patients under legal protection

Treatment and study plan

Patients with a cardiomyopathy

Other

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

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Clémence CHARLON

CONTACT

[email protected]

0033476766652

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Centre Hospitalier Annecy Genevois
  • Centre Hospitalier Metropole Savoie
  • Clinique Belledonne
  • Groupe Hospitalier Mutualiste de Grenoble

Registry information

Acronym: 3CRegistry

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2018
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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