Norwegian Spontaneous Coronary Artery Dissection Study

NCT ID: NCT07317323

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2035-12-31

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:

1. Week 1: Acute hospitalization with CT index and blood samples

2. Week 8: CT control

3. Week 12: Comprehensive physical examination with cardiac exams, blood samples, CPET

4. Week 52: Final follow-up phone call to assess clinical events

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

Conditions

SCAD; Myocardial Infarction (MI); Women

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective

SCAD

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Spontaneous coronary artery dissection

Exclusion Criteria

• Severe kidney failure
• Severe allergic reaction to contrast

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Haukeland University Hospital, Bergen, Norway

UNKNOWN

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: collaborator

Universitetssykehuset i Nord-Norge HF

UNKNOWN

Sponsor Role: collaborator

Ullevaal University Hospital

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

St.Olavs Hospital, Trondheim University Hospital, Norway

UNKNOWN

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mette-Elise Estensen

MD, PhD, Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette Elise Estensen, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

ProCardio, Kardiologisk avdeling Rikshospitalet, Oslo Univeristy Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Akershus University Hospital

Oslo, , Norway

Site Status: RECRUITING

Rikshospitalet, Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Anna Louise Astad Sørlie, MD

Role: CONTACT

anloso@ous-hf.no

+47 926 55 483

Facility Contacts

Nigussie Bogale, MD, PhD

Role: primary

nigussie.bogale@lyse.net

+47 413 09 313

Oliver Meyerdierks, MD, PhD

Role: primary

oliver.meyerdierks@ahus.no

+47 95975609

Anna Louise Astad Sørlie, MD

Role: primary

anloso@ous-hf.no

+47 92655483

Related Links

https://www.oslo-universitetssykehus.no/en/avdelinger/hjerte-lunge-og-karklinikken/procardio-center-for-innovation2/

ProCardio Home site

https://www.oslo-universitetssykehus.no/en/avdelinger/hjerte-lunge-og-karklinikken/procardio-center-for-innovation2/scad-norge/

NOR-SCAD

Other Identifiers

ProCardio

Identifier Type: OTHER

Identifier Source: secondary_id

853139

Identifier Type: -

Identifier Source: org_study_id