NCT05751057

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

January 12, 2023

Last Update Submit

February 20, 2023

Conditions

Non-ST Elevation Myocardial Infarction (NSTEMI)

Keywords

cardiovascular magnetic resonanceMyocardial InfactionInvasive Coronary Angiography

Outcome Measures

Primary Outcomes (1)

  • Reclassification rate

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

    immediately after invasive coronary angiography

Secondary Outcomes (2)

  • Culprit lesion identification

    during invasive coronary angiography

  • Revascularization strategy

    immediately after invasive coronary angiography

Study Arms (1)

NSTEMI patients

EXPERIMENTAL

Patients will undergo CMR before ICA

Diagnostic Test: Cardiovascular Magnetic Resonance

Interventions

Cardiovascular Magnetic ResonanceDIAGNOSTIC_TEST

All NSTEMI patients will undergo to CMR before invasive coronary intervention.

NSTEMI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Anna Giulia Pavon, MD

CONTACT

0041 091 811 5371annagiulia.pavon@eoc.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist, Cardiovascular Imaging Laboratory

Study Record Dates

First Submitted

January 12, 2023

First Posted

March 2, 2023

Study Start

December 14, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations

CH(1)