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Clinical Trials/NCT06506071
NCT06506071
Recruiting
N/A

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

Salamanca University Hospital1 site in 1 country300 target enrollmentSeptember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myocarditis; Acute or Subacute
Sponsor
Salamanca University Hospital
Enrollment
300
Locations
1
Primary Endpoint
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).
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
September 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Salamanca University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Candelas Pérez del Villar

Principal investigator

Salamanca University Hospital

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%.

Outcomes

Primary Outcomes

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).

Time Frame: 2 years

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.

Secondary Outcomes

  • 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.(2 years)
  • To describe the type of perfusion abnormality (hyperemia o perfusion deficit) which correlates with ischaemic and inflammatory,no ischemic myocardial injuries.(2 years)

Study Sites (1)

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