Characterization of Acute Myocardial Damage With Spectral Computed Tomography. (CADAMI-SPECTRAL)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSalamanca University Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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%.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Spectral CT

    Diagnostic test

    Myocardial tissue characterization with Spectral CT

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Case1 intervention
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

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).

To describe the differential alterations in first-pass and late iodine-enhanced images using spectral CT in patients diagnosed with MINOCA, myocarditis, and stress-induced cardiomyopathy, and comparing them with findings obtained by cardiac MRI.

Time frame
2 years

Secondary outcomes

1

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.

Characterize acute myocardial injury using spectral images obtained both in the early (first-pass) phase and in the late gadolinium-enhanced phase after the administration of iodine-based contrast in patients with MINOCA, acute myocarditis, and stress-induced cardiomyopathy, as well as in control subjects.

Time frame
2 years
2

To describe the type of perfusion abnormality (hyperemia o perfusion deficit) which correlates with ischaemic and inflammatory,no ischemic myocardial injuries.

Assess whether spectral CT allows differentiation between the different etiologies of myocardial injury.

Time frame
2 years

Other outcomes

Sponsors and contacts

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Salamanca University Hospital

Lead sponsor

Hospital Universitario Ramon y Cajal

Collaborator