Clinical trial NCT05751057: The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction
Official title: The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction: the TITAN-MRI Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-ST Elevation Myocardial Infarction (NSTEMI)
Keywords: cardiovascular magnetic resonance
Myocardial Infaction
Invasive Coronary Angiography
Lead sponsor: Cardiocentro Ticino
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reclassification rate
timeFrame: immediately after invasive coronary angiography
Secondary outcomes:
measure: Culprit lesion identification
timeFrame: during invasive coronary angiography
measure: Revascularization strategy
timeFrame: immediately after invasive coronary angiography
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino
state: Ticino
Study officials:
References: