Norwegian Spontaneous Coronary Artery Dissection Study | NCT07317323

Studies
Norwegian Spontaneous Coronary Artery Dissection Study

NCT07317323

Sponsor

Oslo University Hospital

Status

Recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

SCAD
Myocardial Infarction (MI)
Women

Interventions

Not provided

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

ID	Type	Description	Link
ProCardio	Other Identifier	Oslo University Hospital

Status Module

Record Verification Date

Dec 2025

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

Apr 1, 2025Actual

Primary Completion Date

Dec 31, 2035Estimated

Completion Date

Dec 31, 2035Estimated

First Submitted Date

Dec 5, 2025

First Submission Date that Met QC Criteria

Dec 18, 2025

First Posted Date

Jan 5, 2026Actual

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

Dec 18, 2025

Last Update Posted Date

Jan 5, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mette-Elise Estensen, MD, PhD, Consultant Cardiologist, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Name	Class
University Hospital, Akershus	OTHER
Haukeland University Hospital, Bergen, Norway	UNKNOWN
Sorlandet Hospital HF	OTHER_GOV
Universitetssykehuset i Nord-Norge HF

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 Norwegian Spontaneous Coronary Artery Dissection Study (NOR-SCAD) is a national, multicenter prospective observational study conducted at major hospitals in Norway. The study investigates risk factors and complications of spontaneous coronary artery dissection (SCAD). Patients aged 18 years or older who are hospitalized with SCAD are recruited during the index hospitalization. Each participant will be followed for 52 weeks with scheduled visits at 8 and 12 weeks and a final phone call at 52 weeks. Evaluations include coronary CT angiography (CTA), cardiac assessments, genetic analyses, blood sampling, structured questionnaires, and a cardiopulmonary exercise test (CPET).

Detailed Description

Background: SCAD has emerged as an important cause of myocardial infarction, especially among women under 60 years of age, and is a leading cause of pregnancy-related myocardial infarction. Despite increased awareness over the past two decades, SCAD remains under-recognized, and management varies widely because of limited evidence. Key gaps persist in understanding SCAD etiology, precipitating factors, optimal diagnostic follow-up (including the role of CTA), and the incidence of complications.

Objectives:

Primary objectives: Determine the incidence and types of complications and major adverse cardiac events (MACE) within the first year after SCAD.

Secondary objectives: Evaluate the diagnostic and follow-up utility of coronary CTA.

Methods:

Multicenter prospective observational cohort study.
Enrollment period: 2025-2035.
Study population: Adults (≥18 years) hospitalized with angiographically or imaging-confirmed SCAD at participating hospitals in Norway.
Follow-up duration: 52 weeks per participant.

Study visits and procedures:

Week 1: Acute hospitalization with CT index and blood samples
Week 8: CT control
Week 12: Comprehensive physical examination with cardiac exams, blood samples, CPET
Week 52: Final follow-up phone call to assess clinical events

Endpoints includes major cardiac events (MACE), CTA findings and quality of life.

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

Retention

Enrollment

300Estimated

Label	Type	Description	Intervention Names
Prospective		SCAD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiac Events	Recurrent myocardial infarction, extra coronary dissection, stroke/TIA, heart failure,	From enrollment to the end of follow-up at 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Assessment of Quality of life	Quality of life assessed by questionnaire WHO-BREF	12 weeks after event
CTA	Computed tomography angiography (CTA) findings

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spontaneous coronary artery dissection

Exclusion Criteria:

Severe kidney failure
Severe allergic reaction to contrast

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

Spontaneous coronary artery dissection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Louise Astad Sørlie, MD	Contact	+47 926 55 483		anloso@ous-hf.no

Overall Officials

Name	Affiliation	Role
Mette Elise Estensen, MD., PhD	ProCardio, Kardiologisk avdeling Rikshospitalet, Oslo Univeristy Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital	Recruiting	Bergen			Norway

Label	URL
ProCardio Home site	View source
NOR-SCAD	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided