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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05751057
Other study ID # 01-TITAN-MRI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 14, 2022
Est. completion date December 31, 2024

Study information

Verified date February 2023
Source Cardiocentro Ticino
Contact Anna Giulia Pavon, MD
Phone 0041 091 811 5371
Email annagiulia.pavon@eoc.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this prospective study is to evaluate the role of cardiovascular magnetic resonance (CMR) in patients with suspected non-ST elevation myocardial infarction (NSTEMI). The main endpoint is the reclassification rate, defined as the number of patients in whom the information provided by pre-angiography CMR affects the revascularization strategy or the final diagnosis. Participants will undergo to CMR before invasive coronary angiography (ICA).


Description:

All patients with NSTEMI eligible for the study undergo CMR prior to ICA. To avoid any delay in patients' treatment all examination will be analyzed by local trained staff at each center. All patients will thereafter undergo ICA and the standard of care (SOC) decision-making on revascularization strategy and diagnosis will be declared by the treating physician, which will be blinded to the participation of the patients in the study and about CMR results. The treating physician will also declare patient's next management according to ICA results. After having declared the diagnosis, the treating physician will then be informed about the CMR findings. Therefore, according to CMR results the treating physician may eventually modify the initial diagnosis and management. Treatment plan modifications include difference in the identification of the culprit lesion, referring the patient to medical therapy instead of a revascularization procedure or viceversa, switching from a percutaneous to a surgical revascularization procedure or viceversa, or need for further cardiac or non-cardiac investigations. Initial diagnosis includes confirmed NSTEMI or all other possible alternative diagnosis and proposed additional diagnostic examination(s) for further differential diagnosis. The CMR-modified SOC (CMR-SOC) and diagnosis made considering CMR results will be collected.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years old - Presence of criteria for acute myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction: - Signs and symptoms of myocardial ischemia - Detection of acute myocardial injury defined as a rise and/or fall of high-sensitivity cardiac Troponin (hs-cTn) values with at least one value above the 99th percentile Upper Reference Limit at baseline or after presentation. - Patients scheduled for ICA. - Written informed consent. Exclusion Criteria: - Patients diagnosed with myocardial infarction with ST segment elevation. - Very High-risk NSTEMI patients according to 2020 ESC Guidelines on Acute Coronary Syndromes: - Haemodynamic instability - Cardiogenic shock - Recurrent/refractory chest pain despite medical treatment - Life-threatening arrhythmias - Mechanical complications of MI - Acute heart failure clearly related to NSTEMI - ST-segment depression>1mm/6 leads plus ST-segment elevation aVR and/or V1. - Legally incompetent to provide informed consent - Participation in another clinical study. - Regular known contraindications to CMR at time of inclusion such as: - Severe renal impairment (eGFR < 30 ml / min / 1,73 m2) or on dialysis treatment - Claustrophobia - Known pregnancy or breast-feeding patients - Non MR compatible devices - Known allergy to Gadolinium

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cardiovascular Magnetic Resonance
All NSTEMI patients will undergo to CMR before invasive coronary intervention.

Locations

Country Name City State
Switzerland Istituto Cardiocentro Ticino Lugano Ticino

Sponsors (1)

Lead Sponsor Collaborator
Cardiocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reclassification rate number of patients in whom the information provided by CMR affects the final diagnosis immediately after invasive coronary angiography
Secondary Culprit lesion identification ability of CMR to detect culprit lesion during invasive coronary angiography
Secondary Revascularization strategy number of patients in whom CMR affects the revascularization strtegy immediately after invasive coronary angiography
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