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

NCT06506071 | Recruiting FDA Device

• 1 other identifier: CADAMI-SPECTRAL
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

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).

  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 Outcomes (2)

• 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 Arms (2)

Case

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

Diagnostic Test: Spectral CT

Controls

Myocardial tissue characterisation using spectral technology and CMR imaging.

Diagnostic Test: Spectral CT

Interventions

Spectral CT DIAGNOSTIC_TEST

Myocardial tissue characterization with Spectral CT

Case; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Salamanca University Hospital: lead
• Hospital Universitario Ramon y Cajal: collaborator

Study Sites (1)

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

Salamanca, 37007, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 34497402 BACKGROUND

• 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.

  PMID: 34167318 BACKGROUND

• 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.

  PMID: 36914247 BACKGROUND

• 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.

  PMID: 26068288 BACKGROUND

MeSH Terms

Conditions

Myocarditis; Takotsubo Cardiomyopathy; Myocardial Infarction

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Candelas Perez-Del Villar, MD, PhD

CONTACT

0034 923291100; mcperezvi@saludcastillayleon.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

ES (1)