Ischemic CardiomyopathyCAMARECNCT03231189
Cardiac MRI in Front Line for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction
An observational study of Ischemic Cardiomyopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy
- How many people
- 415 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2018to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred in one of the participating centers for the etiologic assessment of an unexplained LVEF reduction will be assessed for eligibility. A trans-thoracic echocardiography will be performed in the center at the inclusion as usual, to assess LVEF and confirm the absence of obvious explanation to its reduction. Standard biological tests (included in the standard biological investigation of dilated cardiomyopathy) will be performed to exclude any contraindications to coronary angiography as usual care. They are the same as those required before CMR.
Who may be able to join
- Age ≥ 18 years
- Left Ventricular Ejection Fraction ≤ 45% on transthoracic echocardiography
- Informed signed consent
- Patient having had a preliminary clinical examination
Who cannot join
- Known significant coronary artery stenosis (history of myocardial infarction or coronary artery stenosis).
- Formal indication for coronary angiography other than LV dysfunction (typical angina, acute coronary syndrome, …).
- Obvious etiology for LV dysfunction (valvular, rhythmic…).
- Pregnancy or breastfeeding.
- Other contraindication for CMR (severe allergy to gadolinium known), or coronary artery angiography.
- First diagnosis of LVEF dysfunction > 8 weeks.
- Non covered patient by the social security, the CMU
- Patients under guardianship, or unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicentric Study for the Diagnostic Performance of CArdiac MAgnetic REsonance Imaging Used First for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction
When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is performed. In this situation, the investigators aim to evaluate a strategy with CMR as the front line exam, and invasive coronary angiography performed only in case of ischemic scar on CMR Additionally, a secondary analysis of the collected CMR images will be performed by the MIRACL.AI core lab (AP-HP, Paris) using artificial intelligence (AI) algorithms. This analysis aims to enhance the diagnostic accuracy of coronary artery disease (CAD) detection in patients with reduced left ventricular ejection fraction (rLVEF).
Read the detailed description
Reduced Left Ventricular Ejection Fraction (LVEF) is estimated to be present in 3-7% of the population. With a survival rate between 25-40% at 5 years after a first hospitalization, prognosis of heart failure is similar to that of most cancers. Its treatment and prognosis strongly depend on the etiology, and coronary artery disease is the most frequent one. Identifying coronary artery disease determines care, including medical treatment (aspirin, statins) and revascularization strategies (stent implantation, coronary artery bypass grafting). Once an echocardiography has revealed an LV reduction, with no clear etiology at clinical or echographical examination, coronary angiography is almost systematically performed. But among the 260,000 invasive coronary angiographies performed each year in France (all indications included), 30-60% are "normal" (no obstructive coronary artery).
And among patients with unexplained LV dysfunction, this rate reaches 70-74%… Thus the efficiency of systematic coronary angiography is questionable for these latter. Besides, angiography is invasive, and associated with multiple risks and costs.
Cardiac Magnetic Resonance Imaging (CMR) is very specific and sensitive for detecting myocardial infarction. Small series concluded that a reduction of LVEF due to coronary artery stenosis should have at least one myocardial scar, detected on CMR. But the available data was not enough to change guidelines and clinical practice. In our retrospective study performed on 305 patients, the sensibility of CMR for coronary stenosis was 96%. Furthermore, CMR as a first-line exam would have avoided 71% of coronary angiography, saving 216 days of hospitalization and 329.054 € (1.079€/patient). These results reinforce the previous data but are not definitive.
The aim of this study is to provide a high level of evidence of the benefits and safety of a strategy based on CMR as the front line exam for newly diagnosed systolic dysfunctions.
The primary objective is to evaluate the sensitivity of CMR for predicting the presence of angiographically significant coronary artery stenosis in patients with reduced LVEF. The primary endpoint is the sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.
The objective of the economic evaluation is to estimate the incremental (or decremental) cost effectiveness of using CMR first compared to coronary angiography first.
As part of the secondary analysis, CMR images from the CAMAREC study will be transferred to the Multimodality Imaging for Research and Analysis Core Laboratory for Artificial Intelligence (MIRACL.AI) at AP-HP, Paris. The MIRACL.AI team, led by Dr. Theo Pezel, will apply advanced AI algorithms to detect ischemic patterns and quantify myocardial scarring. This AI analysis aims to improve the sensitivity and specificity of CMR in identifying significant CAD and non-ischemic cardiomyopathies.
For unexplained LV dysfunction, patient will be addressed for CMR first and coronary angiography within 2 weeks after (instead of systematic coronary angiography and unsystematic CMR). CMR and coronary angiography will be performed in all patients. Independent committees will blindly review CMRs and coronary angiographies at the end of the study.
Data from the CAMAREC study will be securely transferred to MIRACL.AI for AI-based analysis. This transfer does not affect the data flow to Lariboisière, nor the confidentiality or the study\'s timeline. MIRACL.AI will solely focus on the AI-enhanced interpretation of the CMR images.
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- Coronary artery disease, cardiac MRI, heart failure
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.
The primary endpoint is the sensitivity (and its 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.
This sensitivity is the following ratio:
Number of patients with an ischemic scar on CMR and a significant coronary artery stenosis on coronary angiography / Number of patients with a significant coronary artery stenosis on coronary angiography.
Measured: up to 8 weeks
Secondary outcomes (9)
Evaluation of the other diagnostic performances indices of CMR for the diagnosis of angiographically significant coronary artery stenosis in patients with reduced LVEF
Sensitivity¸ specificity, positive predictive value and negative predictive value (and their 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF
Measured: up to 8 weeks
Evaluation of the diagnostic performances of CMR for predicting angiographically significant coronary artery stenosis in patients with reduced LVEF requiring revascularization.
Sensitivity¸ specificity, positive predictive value and negative predictive value (and their 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF requiring revascularization
Measured: up to 8 weeks
Analysis of the concordance of CMR and coronary artery angiography in terms of coronary artery territory in patients with coronary stenosis.
κ concordance coefficient between CMR and coronary angiography for the diagnosis of affected myocardial territory in patients with coronary artery stenosis.
Measured: up to 8 weeks
Additional value of CMR for the etiologic diagnosis of reduced LVEF including non-ischemic (LV non compaction, myocarditis …).
Proportion of different etiological diagnosis of reduced LVEF provided only by CMR
Measured: up to 8 weeks
Additional value of CMR for the diagnosis of complications of reduced LVEF (LV thrombus mainly).
Number of patients for whom a complication due to LVEF reduction (LV thrombus, left ventricular dys-synchrony, pre-ruptured left ventricular wall...) is provided only by CMR.
Measured: up to 8 weeks
Additional value of CMR for the decision of coronary artery revascularization.
Proportion of patients with coronary stenosis on the coronary angiography for whom CMR change the decision of revascularization, due to the absence of myocardial viability.
Measured: up to 8 weeks
Evaluate the reproducibility of the interpretations of CMR for ischemic cardiomyopathy.
κ concordance coefficient between the first interpretation of CMR (in the participating centers), and the second (by the CMR reading committee).
Measured: up to 8 weeks
AI-Based Diagnostic Performance of CMR
The MIRACL.IA team will use advanced AI algorithms to detect ischemic patterns.
Measured: At the end of the study (43 months)
AI-Based Diagnostic Performance of CMR
The MIRACL.AI team will apply advanced AI algorithms to quantify myocardial scarring
Measured: At the end onf the study (43months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start15 May 2018
- Primary completion28 Apr 2021
- Study completion31 Aug 2024
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 Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Jondeau, MD,PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231189
- Sponsor's protocol ID
- AOM 16181
- Acronym
- CAMAREC
- Status last verified
- Sep 2024
- First submitted
- 27 Jun 2017
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desroche LM, Darmon A, Lavie-Badie Y, Mandry D, Ducrocq G, Si-Moussi T, Durand-Zaleski I, Millischer D, Milleron O, Huttin O, Valla M, Mangin L, Farah B, Diakov C, Logeart D, Safar B, Travers JY, Mesnier J, Vappereau A, Alfaiate T, Burdet C, Jondeau G; CAMAREC investigators. Diagnostic accuracy of late gadolinium enhancement cardiac MRI for coronary artery disease in patients with reduced left ventricular ejection fraction. Heart. 2025 Sep 25;111(20):969-975. doi: 10.1136/heartjnl-2024-325419.
PubMed 40147871
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Study for the Diagnostic Performance of CArdiac MAgnetic REsonance Imaging Used First for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT03231189
- Acronym / sponsor ID
- CAMAREC / AOM 16181
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- Coronary artery disease, cardiac MRI, heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 27 Jul 2017 (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.
When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is performed. In this situation, the investigators aim to evaluate a strategy with CMR as the front line exam, and invasive coronary angiography performed only in case of ischemic scar on CMR Additionally, a secondary analysis of the collected CMR images will be performed by the MIRACL.AI core lab (AP-HP, Paris) using artificial intelligence (AI) algorithms. This analysis aims to enhance the diagnostic accuracy of coronary artery disease (CAD) detection in patients with reduced left ventricular ejection fraction (rLVEF).
Detailed description
Reduced Left Ventricular Ejection Fraction (LVEF) is estimated to be present in 3-7% of the population. With a survival rate between 25-40% at 5 years after a first hospitalization, prognosis of heart failure is similar to that of most cancers. Its treatment and prognosis strongly depend on the etiology, and coronary artery disease is the most frequent one. Identifying coronary artery disease determines care, including medical treatment (aspirin, statins) and revascularization strategies (stent implantation, coronary artery bypass grafting). Once an echocardiography has revealed an LV reduction, with no clear etiology at clinical or echographical examination, coronary angiography is almost systematically performed. But among the 260,000 invasive coronary angiographies performed each year in France (all indications included), 30-60% are "normal" (no obstructive coronary artery).
And among patients with unexplained LV dysfunction, this rate reaches 70-74%… Thus the efficiency of systematic coronary angiography is questionable for these latter. Besides, angiography is invasive, and associated with multiple risks and costs.
Cardiac Magnetic Resonance Imaging (CMR) is very specific and sensitive for detecting myocardial infarction. Small series concluded that a reduction of LVEF due to coronary artery stenosis should have at least one myocardial scar, detected on CMR. But the available data was not enough to change guidelines and clinical practice. In our retrospective study performed on 305 patients, the sensibility of CMR for coronary stenosis was 96%. Furthermore, CMR as a first-line exam would have avoided 71% of coronary angiography, saving 216 days of hospitalization and 329.054 € (1.079€/patient). These results reinforce the previous data but are not definitive.
The aim of this study is to provide a high level of evidence of the benefits and safety of a strategy based on CMR as the front line exam for newly diagnosed systolic dysfunctions.
The primary objective is to evaluate the sensitivity of CMR for predicting the presence of angiographically significant coronary artery stenosis in patients with reduced LVEF. The primary endpoint is the sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.
The objective of the economic evaluation is to estimate the incremental (or decremental) cost effectiveness of using CMR first compared to coronary angiography first.
As part of the secondary analysis, CMR images from the CAMAREC study will be transferred to the Multimodality Imaging for Research and Analysis Core Laboratory for Artificial Intelligence (MIRACL.AI) at AP-HP, Paris. The MIRACL.AI team, led by Dr. Theo Pezel, will apply advanced AI algorithms to detect ischemic patterns and quantify myocardial scarring. This AI analysis aims to improve the sensitivity and specificity of CMR in identifying significant CAD and non-ischemic cardiomyopathies.
For unexplained LV dysfunction, patient will be addressed for CMR first and coronary angiography within 2 weeks after (instead of systematic coronary angiography and unsystematic CMR). CMR and coronary angiography will be performed in all patients. Independent committees will blindly review CMRs and coronary angiographies at the end of the study.
Data from the CAMAREC study will be securely transferred to MIRACL.AI for AI-based analysis. This transfer does not affect the data flow to Lariboisière, nor the confidentiality or the study\'s timeline. MIRACL.AI will solely focus on the AI-enhanced interpretation of the CMR images.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred in one of the participating centers for the etiologic assessment of an unexplained LVEF reduction will be assessed for eligibility. A trans-thoracic echocardiography will be performed in the center at the inclusion as usual, to assess LVEF and confirm the absence of obvious explanation to its reduction. Standard biological tests (included in the standard biological investigation of dilated cardiomyopathy) will be performed to exclude any contraindications to coronary angiography as usual care. They are the same as those required before CMR.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Left Ventricular Ejection Fraction ≤ 45% on transthoracic echocardiography
- Informed signed consent
- Patient having had a preliminary clinical examination
Key exclusion criteria (8 listed)
- Known significant coronary artery stenosis (history of myocardial infarction or coronary artery stenosis).
- Formal indication for coronary angiography other than LV dysfunction (typical angina, acute coronary syndrome, …).
- Obvious etiology for LV dysfunction (valvular, rhythmic…).
- Pregnancy or breastfeeding.
- Other contraindication for CMR (severe allergy to gadolinium known), or coronary artery angiography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.
Time frame: up to 8 weeks
The primary endpoint is the sensitivity (and its 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF. This sensitivity is the following ratio: Number of patients with an ischemic scar on CMR and a significant coronary artery stenosis on coronary angiography / Number of patients with a significant coronary artery stenosis on coronary angiography.
9 secondary outcomes
Evaluation of the other diagnostic performances indices of CMR for the diagnosis of angiographically significant coronary artery stenosis in patients with reduced LVEF
Time frame: up to 8 weeks
Evaluation of the diagnostic performances of CMR for predicting angiographically significant coronary artery stenosis in patients with reduced LVEF requiring revascularization.
Time frame: up to 8 weeks
Analysis of the concordance of CMR and coronary artery angiography in terms of coronary artery territory in patients with coronary stenosis.
Time frame: up to 8 weeks
Additional value of CMR for the etiologic diagnosis of reduced LVEF including non-ischemic (LV non compaction, myocarditis …).
Time frame: up to 8 weeks
Additional value of CMR for the diagnosis of complications of reduced LVEF (LV thrombus mainly).
Time frame: up to 8 weeks
Additional value of CMR for the decision of coronary artery revascularization.
Time frame: up to 8 weeks
Evaluate the reproducibility of the interpretations of CMR for ischemic cardiomyopathy.
Time frame: up to 8 weeks
AI-Based Diagnostic Performance of CMR
Time frame: At the end of the study (43 months)
AI-Based Diagnostic Performance of CMR
Time frame: At the end onf the study (43months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Results publication: PubMed 40147871Desroche LM, Darmon A, Lavie-Badie Y, Mandry D, Ducrocq G, Si-Moussi T, Durand-Zaleski I, Millischer D, Milleron O, Huttin O, Valla M, Mangin L, Farah B, Diakov C, Logeart D, Safar B, Travers JY, Mesnier J, Vappereau A, Alfaiate T, Burdet C, Jondeau G; CAMAREC investigators. Diagnostic accuracy of late gadolinium enhancement cardiac MRI for coronary artery disease in patients with reduced left ventricular ejection fraction. Heart. 2025 Sep 25;111(20):969-975. doi: 10.1136/heartjnl-2024-325419.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Guillaume Jondeau, MD,PhD study director
Assistance Publique - Hôpitaux de Paris
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 Ischemic Cardiomyopathy, run by Assistance Publique - Hôpitaux de Paris 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 8 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: finished, as of the sponsor's last update on 27 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF. (time frame: up to 8 weeks). 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 NCT03231189, 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 27 Aug 2025.