NCT06506071 Characterization of Acute Myocardial Damage With Spectral Computed Tomography. (CADAMI-SPECTRAL)
| NCT ID | NCT06506071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Salamanca University Hospital |
| Condition | Myocarditis; Acute or Subacute |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2024-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-09-01 with a primary completion date of 2024-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Clinical management of patients with chest pain and elevation of biomarkers of myocardial injury require an accurate diagnosis. Until now, cardiac magnetic resonance imaging (cMRI) is the gold standard for the diagnosis among myocarditis, stress cardiomyopathy, or inapparent ischemic damage. The development of spectral CT has opened up the possibility of characterizing the coronary anatomy and the myocardium in a single procedure. Our aim is to assess the diagnostic ability of differential patterns in first- pass perfusion and delayed iodine enhancement obtained by spectral CT in patients with acute myocardial injury. This study is designed as a prospective multicenter observational study with diagnostic intervention in 150 patients admitted with clinical indication of a cMRI due to suspicion of myocardial infarction with normal coronary arteries (MINOCA), myocarditis or stress cardiomyopathy who will undergo a CT study with double detector technology in two reference centers. A control group (n=150) with an indication for cardiac CT for another cause without coronary or structural heart disease will be included. The iodine maps obtained by spectral CT will be compared with the findings obtained with cMRI, both with conventional techniques and with artificial intelligence algorithms (deep learning). A year follow-up of the cohort will be carried out to assess whether the findings derived from the CT in this group of patients provide prognostic information
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 year. * Hospital admission due to chest pain and acute myocardial injury. * Clinical indication for cardiac MRI (CMR) due to suspected acute myocardial infarction with coronary angiography showing no significant lesions (\<50%) (MINOCA), acute myocarditis, or stress-induced cardiomyopathy. * Signed informed consent. Exclusion Criteria: * Contraindications to undergo cardiac MRI and CT with administration of gadolinium and/or iodine-based contrast, respectively. * Pre-existing cardiomyopathy. * Pre-existing chronic ischemic heart disease. * Invasive coronary angiography showing coronary lesions ≥50%.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06506071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocarditis; Acute or Subacute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06506071 currently recruiting?
Yes, NCT06506071 is actively recruiting participants. Contact the research team at mcperezvi@saludcastillayleon.es for enrollment information.
Where is the NCT06506071 trial being conducted?
This trial is being conducted at Salamanca, Spain.
Who is sponsoring the NCT06506071 clinical trial?
NCT06506071 is sponsored by Salamanca University Hospital. The trial plans to enroll 300 participants.