Non-ST Elevation Myocardial Infarction (NSTEMI)TITAN-MRINCT05751057
The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction
A study testing Cardiovascular Magnetic Resonance in people with Non-ST Elevation Myocardial Infarction (NSTEMI), run by Cardiocentro Ticino at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction (NSTEMI)
- What is being tested?
- Cardiovascular Magnetic Resonance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Dec 2022to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Istituto Cardiocentro Ticino
Lugano, Canton Ticino, 6900
Anna Giulia Pavon, MD, 0041 091 811 5371, annagiulia.pavon@eoc.ch
About this study
Official title: 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).
Read the 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.
- Being tested
- Cardiovascular Magnetic Resonance
- Keywords
- cardiovascular magnetic resonance, Myocardial Infaction, Invasive Coronary Angiography
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic ResonanceDiagnostic test
All NSTEMI patients will undergo to CMR before invasive coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| NSTEMI patients | Experimental | Patients will undergo CMR before ICA Receives: Diagnostic Test: Cardiovascular Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reclassification rate
number of patients in whom the information provided by CMR affects the final diagnosis
Measured: immediately after invasive coronary angiography
Secondary outcomes (2)
Culprit lesion identification
ability of CMR to detect culprit lesion
Measured: during invasive coronary angiography
Revascularization strategy
number of patients in whom CMR affects the revascularization strtegy
Measured: immediately after invasive coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start14 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST Elevation Myocardial Infarction (NSTEMI)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiocentro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Giulia Pavon, Cardiocentro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751057
- Sponsor's protocol ID
- 01-TITAN-MRI
- Acronym
- TITAN-MRI
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be avaliable under specific request to Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction: the TITAN-MRI Study
- ClinicalTrials.gov ID
- NCT05751057
- Acronym / sponsor ID
- TITAN-MRI / 01-TITAN-MRI
- Keywords
- cardiovascular magnetic resonance, Myocardial Infaction, Invasive Coronary Angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cardiocentro TicinoUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Mar 2023 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSTEMI patients | Experimental | Diagnostic Test: Cardiovascular Magnetic ResonancePatients will undergo CMR before ICA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Cardiovascular Magnetic ResonanceAll NSTEMI patients will undergo to CMR before invasive coronary intervention. | Diagnostic test | NSTEMI patients |
Primary outcome
Reclassification rate
Time frame: immediately after invasive coronary angiography
number of patients in whom the information provided by CMR affects the final diagnosis
2 secondary outcomes
Culprit lesion identification
Time frame: during invasive coronary angiography
Revascularization strategy
Time frame: immediately after invasive coronary angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided. Data will be avaliable under specific request to Principal Investigator
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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?
A study testing Cardiovascular Magnetic Resonance in people with Non-ST Elevation Myocardial Infarction (NSTEMI), run by Cardiocentro Ticino at 1 site in Switzerland.
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 6 inclusion and 17 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 2 Mar 2023. 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 Switzerland. 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 Anna Giulia Pavon, MD (0041 091 811 5371, annagiulia.pavon@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reclassification rate (time frame: immediately after invasive coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.