Plaque Burden and Ischemia in MINOCA | NCT05681858

Studies
Plaque Burden and Ischemia in MINOCA

NCT05681858

Sponsor

University of Bergen

Status

Recruiting

Last Update Posted

Dec 4, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

MINOCA

Interventions

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

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2023Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Jan 3, 2023

First Submission Date that Met QC Criteria

Jan 3, 2023

First Posted Date

Jan 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2023

Last Update Posted Date

Dec 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mai Tone Lønnebakken, Professor M.D., University of BergenPrincipal Investigator

Lead Sponsor

University of BergenOTHER

Collaborators

Name	Class
Haukeland University Hospital	OTHER
Haraldsplass Deaconess Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CT coronary angiography and [12N] NH3 PET-MR	Diagnostic Test	Advanced coronary artery plaque analysis, myocardial ischemia and coronary flow reserve	CT coronary angiography and [12N] NH3 PET-MR

Measure	Description	Time Frame
Plaque burden		1 week
Myocardial ischemia		1 week

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Science, University of Bergen	Recruiting	Bergen		5021	Norway

Condition Browse Module

MeSH Terms

ID	Term
D000088442	MINOCA

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided