Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06506071

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Asistencial Universitario de Salamanca. Instituto de Investigación Biomédica de Salamanca

Salamanca, 37007, Spain

Location status: Recruiting

Location contact

Candelas Pérez del Villar Moro, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Spectral CT

Diagnostic Test

Myocardial tissue characterization with Spectral CT

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).

    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

  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.

    Time frame: 2 years

    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.

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

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Candelas Perez-Del Villar, MD, PhD

CONTACT

[email protected]

0034 923291100 ext. 55673

Sponsors and collaborators

Lead sponsor

Salamanca University Hospital

Other

Collaborators

  • Hospital Universitario Ramon y Cajal

Registry information

Official study title

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

Acronym: CADAMI

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.