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Plaque Burden and Ischemia in MINOCA

Primary Purpose

MINOCA

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
CT coronary angiography and [12N] NH3 PET-MR
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for MINOCA

Eligibility Criteria

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

Sites / Locations

  • Department of Clinical Science, University of BergenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Plaque burden
Myocardial ischemia

Secondary Outcome Measures

Full Information

First Posted
January 3, 2023
Last Updated
January 3, 2023
Sponsor
University of Bergen
Collaborators
Haukeland University Hospital, Haraldsplass Deaconess Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05681858
Brief Title
Plaque Burden and Ischemia in MINOCA
Official Title
Coronary Artery Plaque, Perivascular Inflammation and Myocardial Ischemia in Patients With Myocardial Infraction and Non-obstructive Coronary Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
Haukeland University Hospital, Haraldsplass Deaconess Hospital

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MINOCA

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CT coronary angiography and [12N] NH3 PET-MR
Arm Type
Other
Arm Description
All patients will undergo CT coronary angiography and stress [12N] NH3 PET-MR
Intervention Type
Diagnostic Test
Intervention Name(s)
CT coronary angiography and [12N] NH3 PET-MR
Intervention Description
Advanced coronary artery plaque analysis, myocardial ischemia and coronary flow reserve
Primary Outcome Measure Information:
Title
Plaque burden
Time Frame
1 week
Title
Myocardial ischemia
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Clinical Science, University of Bergen
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai Tone Lønnebakken, MD phd
Phone
+47 55972220
Email
mai.lonnebakken@uib.no
First Name & Middle Initial & Last Name & Degree
Terje H Larsen, MD phd
Phone
+4755975000
Email
terje.hjalmar.larsen@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Terje H Larsen, MD phd
First Name & Middle Initial & Last Name & Degree
Silja Hanseth, MD

12. IPD Sharing Statement

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Plaque Burden and Ischemia in MINOCA

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