Myocarditis; Acute or SubacuteCADAMINCT06506071
Characterization of Acute Myocardial Damage With Spectral Computed Tomography. (CADAMI-SPECTRAL)
An observational study of Myocarditis; Acute or Subacute and Takotsubo Cardiomyopathy, run by Salamanca University Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocarditis; Acute or Subacute, Takotsubo Cardiomyopathy, Infarction, Myocardial
- What is being tested?
- Spectral CT
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complejo Asistencial Universitario de Salamanca. Instituto de Investigación Biomédica de Salamanca
Salamanca, 37007
Candelas Pérez del Villar Moro, MD, PhD
About this study
Official title: 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
- Conditions
- Myocarditis; Acute or Subacute, Takotsubo Cardiomyopathy, Infarction, Myocardial, Myocardial Injury
- Being tested
- Spectral CT
- Medical subject headings
- Myocarditis, Takotsubo Cardiomyopathy, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral CTDiagnostic test
Myocardial tissue characterization with Spectral CT
| Study group | Role | What they receive |
|---|---|---|
| Case | Myocardial tissue characterisation using spectral technology and Cardiac Magnetic Resonance (CMR) imaging. Receives: Diagnostic Test: Spectral CT | |
| Controls | Myocardial tissue characterisation using spectral technology and CMR imaging. Receives: Diagnostic Test: Spectral CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 2 years
To describe the type of perfusion abnormality (hyperemia o perfusion deficit) which correlates with ischaemic and inflammatory,no ischemic myocardial injuries.
Assess whether spectral CT allows differentiation between the different etiologies of myocardial injury.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocarditis; Acute or SubacuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salamanca University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal
- Responsible party
- Principal investigator, Candelas Pérez del Villar, Salamanca University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506071
- Sponsor's protocol ID
- CADAMI-SPECTRAL
- Acronym
- CADAMI
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34497402Wereski 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.
PubMed 34167318Greer 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.
PubMed 36914247Danad 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.
PubMed 26068288
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Acute Myocardial Damage With Spectral Computed Tomography. CADAMI-SPECTRAL.
- ClinicalTrials.gov ID
- NCT06506071
- Acronym / sponsor ID
- CADAMI / CADAMI-SPECTRAL
- Conditions
- Myocarditis; Acute or Subacute, Takotsubo Cardiomyopathy, Infarction, Myocardial, Myocardial Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Salamanca University HospitalUniversity, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: Spectral CTMyocardial tissue characterisation using spectral technology and Cardiac Magnetic Resonance (CMR) imaging. |
| Controls | – | Diagnostic Test: Spectral CTMyocardial tissue characterisation using spectral technology and CMR imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectral CTMyocardial tissue characterization with Spectral CT | Diagnostic test | Case, Controls |
Primary outcome
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 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 34497402Townsend 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.
- Background: PubMed 34167318Wereski 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.
- Background: PubMed 36914247Greer 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.
- Background: PubMed 26068288Danad 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis; Acute or Subacute and Takotsubo Cardiomyopathy, run by Salamanca University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Candelas Perez-Del Villar, MD, PhD (0034 923291100 ext. 55673, mcperezvi@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06506071, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.