Plaque Burden and Ischemia in MINOCA

Sponsor

University of Bergen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05681858

Collaborator

Haukeland University Hospital (Other), Haraldsplass Deaconess Hospital (Other)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
MINOCA	Diagnostic Test: CT coronary angiography and [12N] NH3 PET-MR	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Coronary Artery Plaque, Perivascular Inflammation and Myocardial Ischemia in Patients With Myocardial Infraction and Non-obstructive Coronary Arteries

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Advanced coronary artery plaque analysis, myocardial ischemia and coronary flow reserve

Arm

Intervention/Treatment

Other: 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

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

Outcome Measures

Primary Outcome Measures

Plaque burden [1 week]
Myocardial ischemia [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Science, University of Bergen	Bergen		Norway	5021

Sponsors and Collaborators

University of Bergen
Haukeland University Hospital
Haraldsplass Deaconess Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mai Tone Lønnebakken, Professor M.D., University of Bergen

ClinicalTrials.gov Identifier:

NCT05681858

Other Study ID Numbers:

463549

First Posted:

Jan 12, 2023

Last Update Posted:

Jan 12, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ischemia

Study Results

No Results Posted as of Jan 12, 2023