NCT05681858

Brief Summary

The goal of this clinical trial is to assess coronary artery plaque burden, perivascular inflammation and extent of myocardial ischemia in patients presenting with acute myocardial infarction and non-obstructive coronary artery disease. The main question it aims to answer are:

  • Identify coronary artery anatomy, plaque burden, composition and high-risk plaque features by CT coronary angiography in MINOCA
  • Assess presence, extent and severity of myocardial ischemia in MINOCA Participants will examined by CT coronary angiography and stress \[12N\] NH3 PET-MR.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress69%
Aug 2023Aug 2027

First Submitted

Initial submission to the registry

January 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

January 3, 2023

Last Update Submit

November 28, 2023

Conditions

MINOCA

Outcome Measures

Primary Outcomes (2)

  • Plaque burden

    1 week

  • Myocardial ischemia

    1 week

Study Arms (1)

CT coronary angiography and [12N] NH3 PET-MR

All patients will undergo CT coronary angiography and stress \[12N\] NH3 PET-MR

Diagnostic Test: CT coronary angiography and [12N] NH3 PET-MR

Interventions

CT coronary angiography and [12N] NH3 PET-MRDIAGNOSTIC_TEST

Advanced coronary artery plaque analysis, myocardial ischemia and coronary flow reserve

CT coronary angiography and [12N] NH3 PET-MR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized with acute myocardial infarction and non-obstructive coronary artery disease by coronary angiography

You may qualify if:

  • Acute chest pain
  • Elevated troponin
  • Non-obstructive coronary arteries by coronary angiography

You may not qualify if:

  • Obstructive coronary artery disease
  • Contraindications against CT coronary angiography or stress \[12N\] NH3 PET-MR
  • Not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Science, University of Bergen

Bergen, 5021, Norway

RECRUITING

MeSH Terms

Conditions

MINOCA

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor M.D.

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 12, 2023

Study Start

August 15, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations

NO(1)