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

Primary Purpose

Non-ST Elevation Myocardial Infarction (NSTEMI)

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cardiovascular Magnetic Resonance
Sponsored by
Cardiocentro Ticino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-ST Elevation Myocardial Infarction (NSTEMI) focused on measuring cardiovascular magnetic resonance, Myocardial Infaction, Invasive Coronary Angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Cardiocentro TicinoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NSTEMI patients

Arm Description

Patients will undergo CMR before ICA

Outcomes

Primary Outcome Measures

Reclassification rate
number of patients in whom the information provided by CMR affects the final diagnosis

Secondary Outcome Measures

Culprit lesion identification
ability of CMR to detect culprit lesion
Revascularization strategy
number of patients in whom CMR affects the revascularization strtegy

Full Information

First Posted
January 12, 2023
Last Updated
February 20, 2023
Sponsor
Cardiocentro Ticino
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1. Study Identification

Unique Protocol Identification Number
NCT05751057
Brief Title
The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction
Acronym
TITAN-MRI
Official Title
The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction: the TITAN-MRI Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiocentro Ticino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST Elevation Myocardial Infarction (NSTEMI)
Keywords
cardiovascular magnetic resonance, Myocardial Infaction, Invasive Coronary Angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NSTEMI patients
Arm Type
Experimental
Arm Description
Patients will undergo CMR before ICA
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiovascular Magnetic Resonance
Intervention Description
All NSTEMI patients will undergo to CMR before invasive coronary intervention.
Primary Outcome Measure Information:
Title
Reclassification rate
Description
number of patients in whom the information provided by CMR affects the final diagnosis
Time Frame
immediately after invasive coronary angiography
Secondary Outcome Measure Information:
Title
Culprit lesion identification
Description
ability of CMR to detect culprit lesion
Time Frame
during invasive coronary angiography
Title
Revascularization strategy
Description
number of patients in whom CMR affects the revascularization strtegy
Time Frame
immediately after invasive coronary angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Giulia Pavon, MD
Phone
0041 091 811 5371
Email
annagiulia.pavon@eoc.ch
Facility Information:
Facility Name
Istituto Cardiocentro Ticino
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Giulia Pavon, MD
Phone
0041 091 811 5371
Email
annagiulia.pavon@eoc.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be avaliable under specific request to Principal Investigator

Learn more about this trial

The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction

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