deltatrials
Recruiting OBSERVATIONAL NCT03479580

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

Sponsor: Centre Hospitalier Annecy Genevois

Updated 7 times since 2018 Last updated: May 18, 2022 Started: Feb 8, 2018 Primary completion: Feb 29, 2028 Completion: Feb 29, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Dilated Cardiomyopathies and Hypertrophic and is currently actively recruiting participants. Centre Hospitalier Annecy Genevois leads this study, which shows 7 recorded versions since 2018 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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...

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.

Status Flow

~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotRecruiting~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotRecruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotRecruiting~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshotRecruiting~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – present · 19 months · monthly snapshotRecruiting

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Recruiting

  2. Jul 2024 — Sep 2024 [monthly]

    Recruiting

  3. Jun 2022 — Jul 2024 [monthly]

    Recruiting

  4. Jan 2021 — Jun 2022 [monthly]

    Recruiting

  5. Nov 2020 — Jan 2021 [monthly]

    Recruiting

Show 2 earlier versions
  1. Jun 2018 — Nov 2020 [monthly]

    Recruiting

  2. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    First recorded

Feb 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Centre Hospitalier Annecy Genevois
  • Centre Hospitalier Metropole Savoie
  • Clinique Belledonne
  • Groupe Hospitalier Mutualiste de Grenoble
  • University Hospital, Grenoble
Data source: University Hospital, Grenoble

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations