ClinicalTrials.gg
RecruitingNCT05681858Updated Dec 4, 2023

Plaque Burden and Ischemia in MINOCA

An observational study in MINOCA, sponsored by University of Bergen. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by University of Bergen · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • MINOCA

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03

In context

MINOCA

29 studies on the registry are indexed under MINOCA; 18 are open to participants now.

This study's planned enrollment of 100 is below the median of 500 across 20 observational studies indexed under MINOCA.

Browse MINOCA studies →

Lead sponsor

University of Bergen is the lead sponsor of 143 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Obstructive coronary artery disease
  • against CT coronary angiography or stress [12N] NH3 PET-MR
  • Not able to give
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testCT coronary angiography and [12N] NH3 PET-MR

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

06

What researchers measure

Primary outcomes

  1. Plaque burden

    Time frame: 1 week

  2. Myocardial ischemia

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • Department of Clinical Science, University of Bergen
    Bergen, 5021, Norway
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05681858
Collaborators
Haukeland University Hospital, Haraldsplass Deaconess Hospital
Responsible party
Mai Tone Lønnebakken (Professor M.D., University of Bergen) — Principal investigator
First posted
Jan 12, 2023
Start date
Aug 15, 2023
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Dec 4, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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