The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction (TITAN-MRI)

February 20, 2023 updated by: Anna Giulia Pavon, Cardiocentro Ticino

The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction: the TITAN-MRI Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Recruiting
        • Istituto Cardiocentro Ticino
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSTEMI patients
Patients will undergo CMR before ICA
Diagnostic test: Cardiovascular Magnetic Resonance
All NSTEMI patients will undergo to CMR before invasive coronary intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reclassification rate
Time Frame: immediately after invasive coronary angiography
number of patients in whom the information provided by CMR affects the final diagnosis
immediately after invasive coronary angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Culprit lesion identification
Time Frame: during invasive coronary angiography
ability of CMR to detect culprit lesion
during invasive coronary angiography
Revascularization strategy
Time Frame: immediately after invasive coronary angiography
number of patients in whom CMR affects the revascularization strtegy
immediately after invasive coronary angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiocentro Ticino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-TITAN-MRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be avaliable under specific request to Principal Investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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