Clinical trial NCT06506071: Characterization of Acute Myocardial Damage With Spectral Computed Tomography. (CADAMI-SPECTRAL)
Official title: Characterization of Acute Myocardial Damage With Spectral Computed Tomography. CADAMI-SPECTRAL.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocarditis; Acute or Subacute
Takotsubo Cardiomyopathy
Infarction, Myocardial
Myocardial Injury
Lead sponsor: Salamanca University Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Ramon y Cajal
First posted: 2024-07-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted with a suspected diagnosis of acute myocardial injury or subjects with a clinical indication for cardiac CT (CCT) for other reasons without myocardial injury or previous structural heart disease, with ≤1 cardiovascular risk factor, left ventricular ejection fraction \> 55%, and absence of significant valvular disease (grade \< III), with a similar age and sex distribution to cases with a clinical indication for CCT for other reasons.

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%.

Primary outcomes:
measure: Correlation between volume of myocardium with abnormal perfusion (measured using spectral iodine density images) and percentage of myocardium with late gadolinium enhacement -LGE- (measured by CMR).
timeFrame: 2 years
Secondary outcomes:
measure: Characterize acute myocardial injury using spectral images obtained after the administration of iodine-based contrast in patients with MINOCA, acute myocarditis, and stress-induced cardiomyopathy, as well as in control subjects.
timeFrame: 2 years
measure: To describe the type of perfusion abnormality (hyperemia o perfusion deficit) which correlates with ischaemic and inflammatory,no ischemic myocardial injuries.
timeFrame: 2 years
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca. Instituto de Investigación Biomédica de Salamanca
Study officials:
References:
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citation: Wereski R, Kimenai DM, Taggart C, Doudesis D, Lee KK, Lowry MTH, Bularga A, Lowe DJ, Fujisawa T, Apple FS, Collinson PO, Anand A, Chapman AR, Mills NL. Cardiac Troponin Thresholds and Kinetics to Differentiate Myocardial Injury and Myocardial Infarction. Circulation. 2021 Aug 17;144(7):528-538. doi: 10.1161/CIRCULATIONAHA.121.054302. Epub 2021 Jun 25.
citation: Greer C, Williams MC, Newby DE, Adamson PD. Role of computed tomography cardiac angiography in acute chest pain syndromes. Heart. 2023 Aug 24;109(18):1350-1356. doi: 10.1136/heartjnl-2022-321360.
citation: Danad I, Fayad ZA, Willemink MJ, Min JK. New Applications of Cardiac Computed Tomography: Dual-Energy, Spectral, and Molecular CT Imaging. JACC Cardiovasc Imaging. 2015 Jun;8(6):710-23. doi: 10.1016/j.jcmg.2015.03.005.