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

S

Salamanca University Hospital

Status

Enrolling

Conditions

Infarction, Myocardial
Myocarditis; Acute or Subacute
Takotsubo Cardiomyopathy
Myocardial Injury

Treatments

Diagnostic Test: Spectral CT

Study type

Observational

Funder types

Other

Identifiers

NCT06506071
CADAMI-SPECTRAL

Details and patient eligibility

About

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

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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%.

Trial design

300 participants in 2 patient groups

Case
Description:
Myocardial tissue characterisation using spectral technology and Cardiac Magnetic Resonance (CMR) imaging.
Treatment:
Diagnostic Test: Spectral CT
Controls
Description:
Myocardial tissue characterisation using spectral technology and CMR imaging.
Treatment:
Diagnostic Test: Spectral CT

Trial contacts and locations

1

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Central trial contact

Candelas Perez-Del Villar, MD, PhD

Data sourced from clinicaltrials.gov

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