Hypertrophic3CRegistryNCT03479580
Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry
An observational study of Hypertrophic and Ischemic, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Long-term prognostic value of macrovascular and microvascular coronary artery stenoses in each type of cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertrophic, Ischemic, Restrictive Cardiomyopathy
- What is being tested?
- Patients with a cardiomyopathy
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2018to Feb 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a cardiomyopathy
Who may be able to join
- Ischemic
- Dilated
- Hypertrophic
- Restrictive cardiomyopathy.
Who cannot join
- Pregnant women
- Breastfeeding women
- Patients under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
La Tronche, 38700
Gilles BARONE-ROCHETTE, MD, PHD
Clémence CHARLON, ARC, 0033476766652, ccharlon@chu-grenoble.fr
About this study
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.
- Being tested
- Patients with a cardiomyopathy
- Keywords
- Cardiomyopathy, Multimodal imaging, Coronary artery disease, Coronary microvascular disease, Prognosis, Atherosclerosis, Myocardial ischemia
- Medical subject headings
- Hypertrophy, Ischemia, Cardiomyopathy, Restrictive, Cardiomyopathy, Dilated, Cardiomyopathies, Coronary Artery Disease, Microvascular Angina, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with a cardiomyopathyOther
Prognostic value of coronary artery disease and microvascular disease in the different types of cardiomyopathies.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start8 Feb 2018
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertrophicStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Belledonne, Groupe Hospitalier Mutualiste de Grenoble, Centre Hospitalier Annecy Genevois, Centre Hospitalier Metropole Savoie
- Responsible party
- Sponsor
- Investigators
- Gilles BARONE-ROCHETTE, PI, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479580
- Sponsor's protocol ID
- 38RC17.215
- Other IDs
- 2017-A02064-49
- Acronym
- 3CRegistry
- Status last verified
- May 2022
- First submitted
- 23 Jan 2018
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brunel L, Pioch N, Caullery B, Marzouki IE, Barone-Rochette G. Validity of angiography-derived microvascular resistance in hypertrophic cardiomyopathy: a head-to-head comparison with pressure-wire IMR. Int J Cardiovasc Imaging. 2026 Sep 23. doi: 10.1007/s10554-026-03834-2. Online ahead of print.
PubMed 42776391
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry
- ClinicalTrials.gov ID
- NCT03479580
- Acronym / sponsor ID
- 3CRegistry / 38RC17.215
- Keywords
- Cardiomyopathy, Multimodal imaging, Coronary artery disease, Coronary microvascular disease, Prognosis, Atherosclerosis, Myocardial ischemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinique Belledonne, Groupe Hospitalier Mutualiste de Grenoble, Centre Hospitalier Annecy Genevois, Centre Hospitalier Metropole Savoie
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a cardiomyopathy
Key inclusion criteria (4 listed)
- Ischemic
- Dilated
- Hypertrophic
- Restrictive cardiomyopathy.
Key exclusion criteria (3 listed)
- Pregnant women
- Breastfeeding women
- Patients under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with a cardiomyopathyPrognostic value of coronary artery disease and microvascular disease in the different types of cardiomyopathies. | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 42776391Brunel L, Pioch N, Caullery B, Marzouki IE, Barone-Rochette G. Validity of angiography-derived microvascular resistance in hypertrophic cardiomyopathy: a head-to-head comparison with pressure-wire IMR. Int J Cardiovasc Imaging. 2026 Sep 23. doi: 10.1007/s10554-026-03834-2. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilles BARONE-ROCHETTE, PI principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic and Ischemic, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clémence CHARLON (0033476766652, ccharlon@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.