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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06506071
Acronym
CADAMI
Enrollment
300
Registered
2024-07-17
Start date
2022-09-01
Completion date
2025-09-01
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DIAGNOSTIC_TESTSpectral CT

Myocardial tissue characterization with Spectral CT

Sponsors

Hospital Universitario Ramon y Cajal
CollaboratorOTHER
Salamanca University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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%.

Design outcomes

Primary

MeasureTime frameDescription
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).2 yearsTo 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

MeasureTime frameDescription
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 yearsCharacterize 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.
To describe the type of perfusion abnormality (hyperemia o perfusion deficit) which correlates with ischaemic and inflammatory,no ischemic myocardial injuries.2 yearsAssess whether spectral CT allows differentiation between the different etiologies of myocardial injury.

Countries

Spain

Contacts

Primary ContactCandelas Perez-Del Villar, MD, PhD
mcperezvi@saludcastillayleon.es0034 923291100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026