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

July 19, 2024 updated by: Candelas Pérez del Villar, Salamanca University Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • Recruiting
        • Complejo Asistencial Universitario de Salamanca. Instituto de Investigación Biomédica de Salamanca
        • Principal Investigator:
          • Candelas Pérez del Villar Moro, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Myocardial tissue characterisation using spectral technology and Cardiac Magnetic Resonance (CMR) imaging.
Diagnostic test: Spectral CT
Myocardial tissue characterization with Spectral CT
Controls
Myocardial tissue characterisation using spectral technology and CMR imaging.
Diagnostic test: Spectral CT
Myocardial tissue characterization with Spectral CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salamanca University Hospital

Collaborators

Hospital Universitario Ramon y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CADAMI-SPECTRAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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