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

NCT ID: NCT06506071

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-09-01

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Case

Myocardial tissue characterisation using spectral technology and Cardiac Magnetic Resonance (CMR) imaging.

Spectral CT

Intervention Type DIAGNOSTIC_TEST

Myocardial tissue characterization with Spectral CT

Controls

Myocardial tissue characterisation using spectral technology and CMR imaging.

Spectral CT

Intervention Type DIAGNOSTIC_TEST

Myocardial tissue characterization with Spectral CT

Interventions

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Spectral CT

Myocardial tissue characterization with Spectral CT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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%.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role collaborator

Salamanca University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Candelas Pérez del Villar

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Salamanca, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Candelas Perez-Del Villar, MD, PhD

Role: CONTACT

0034 923291100 ext. 55673

References

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Townsend N, Kazakiewicz D, Lucy Wright F, Timmis A, Huculeci R, Torbica A, Gale CP, Achenbach S, Weidinger F, Vardas P. Epidemiology of cardiovascular disease in Europe. Nat Rev Cardiol. 2022 Feb;19(2):133-143. doi: 10.1038/s41569-021-00607-3. Epub 2021 Sep 8.

Reference Type BACKGROUND
PMID: 34497402 (View on PubMed)

Wereski R, Kimenai DM, Taggart C, Doudesis D, Lee KK, Lowry MTH, Bularga A, Lowe DJ, Fujisawa T, Apple FS, Collinson PO, Anand A, Chapman AR, Mills NL. Cardiac Troponin Thresholds and Kinetics to Differentiate Myocardial Injury and Myocardial Infarction. Circulation. 2021 Aug 17;144(7):528-538. doi: 10.1161/CIRCULATIONAHA.121.054302. Epub 2021 Jun 25.

Reference Type BACKGROUND
PMID: 34167318 (View on PubMed)

Greer C, Williams MC, Newby DE, Adamson PD. Role of computed tomography cardiac angiography in acute chest pain syndromes. Heart. 2023 Aug 24;109(18):1350-1356. doi: 10.1136/heartjnl-2022-321360.

Reference Type BACKGROUND
PMID: 36914247 (View on PubMed)

Danad I, Fayad ZA, Willemink MJ, Min JK. New Applications of Cardiac Computed Tomography: Dual-Energy, Spectral, and Molecular CT Imaging. JACC Cardiovasc Imaging. 2015 Jun;8(6):710-23. doi: 10.1016/j.jcmg.2015.03.005.

Reference Type BACKGROUND
PMID: 26068288 (View on PubMed)

Other Identifiers

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CADAMI-SPECTRAL

Identifier Type: -

Identifier Source: org_study_id

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