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RecruitingNCT034795803CRegistryUpdated May 19, 2022

Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

An observational study in Hypertrophic, Ischemic and Restrictive Cardiomyopathy, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-05-19.

Primary conditionCardiomyopathy, DilatedRegistry: HypertrophyReclassifiedWhy we changed it
Registry
Hypertrophy — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cardiomyopathy, Dilated
Why
  1. The study's listed conditions name Cardiomyopathy, Dilated, a narrower term within Hypertrophy.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Grenoble · Observational

From the registry’s dates

  • Started Feb 2018; still recruiting 8 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,600
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hypertrophic
  • Ischemic
  • Restrictive Cardiomyopathy
  • Dilated Cardiomyopathies

Keywords

  • Cardiomyopathy
  • Multimodal imaging
  • Coronary artery disease
  • Coronary microvascular disease
  • Prognosis
  • Atherosclerosis
  • Myocardial ischemia
03

In context

Cardiomyopathy, Dilated Reclassified

255 studies on the registry are indexed under Cardiomyopathy, Dilated; 66 are open to participants now.

This study's planned enrollment of 1,600 is above the median of 245 across 96 observational studies indexed under Cardiomyopathy, Dilated.

Browse Cardiomyopathy, Dilated studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.

Browse University Hospital, Grenoble studies →

Compared within Cardiomyopathy, Dilated, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertrophy. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with a cardiomyopathy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ischemic
  • Dilated
  • Hypertrophic
  • Restrictive cardiomyopathy.

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Breastfeeding women
  • Patients under legal protection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,600 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • OtherPatients with a cardiomyopathy

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

06

What researchers measure

Primary outcomes

  1. Major Adverse Cardiovascular Events

    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

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • University Hospital Grenoble
    La Tronche, 38700, France
    Recruiting
    • Gilles BARONE-ROCHETTE, MD, PHD · Contact
    • Clémence CHARLON, ARC · Contactccharlon@chu-grenoble.fr · 0033476766652
    • 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 · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Feb 2028, 120 months after the start.

Of 50 observational studies under Cardiomyopathy, Dilated, half reached primary completion within 95 months of starting (the median), counting those still running; a quarter within 51 and three quarters within 101. This study's planned 120 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Mar 27, 2018
StartActual
Feb 8, 2018
Primary completionEst.
Feb 2028
CompletionEst.
Feb 2028
Last update
May 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03479580
Lead sponsor
University Hospital, Grenoble
Collaborators
Clinique Belledonne, Groupe Hospitalier Mutualiste de Grenoble, Centre Hospitalier Annecy Genevois, Centre Hospitalier Metropole Savoie
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Feb 8, 2018
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
May 19, 2022

Study contacts

Clémence CHARLON
Contact
ccharlon@chu-grenoble.fr
0033476766652
Gilles BARONE-ROCHETTE, PI
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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