Norwegian Spontaneous Coronary Artery Dissection Study (NOR-SCAD)

Norwegian Spontaneous Coronary Artery Dissection Study (NOR-SCAD Study)

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).

Study Overview

• Status: Recruiting
• Conditions: SCAD; Women; Myocardial Infarction (MI)

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Anna Louise Astad Sørlie, MD; Phone Number: +47 926 55 483; Email: anloso@ous-hf.no

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Nigussie Bogale, MD, PhD; Phone Number: +47 413 09 313; Email: nigussie.bogale@lyse.net
  • Oslo, Norway
    • Recruiting
    • Akershus University Hospital
    • Contact: Oliver Meyerdierks, MD, PhD; Phone Number: +47 95975609; Email: oliver.meyerdierks@ahus.no
  • Oslo, Norway
    • Recruiting
    • Rikshospitalet, Oslo University Hospital
    • Contact: Anna Louise Astad Sørlie, MD; Phone Number: +47 92655483; Email: anloso@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Spontaneous coronary artery dissection

Description

Inclusion Criteria:

• Spontaneous coronary artery dissection

Exclusion Criteria:

• Severe kidney failure
• Severe allergic reaction to contrast

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Prospective; SCAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Acute and after 12 weeks

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Ullevaal University Hospital; Helse Stavanger HF; Sorlandet Hospital HF; University Hospital, Akershus; St.Olavs Hospital, Trondheim University Hospital, Norway; Universitetssykehuset i Nord-Norge HF; Haukeland University Hospital, Bergen, Norway
• Investigators: Principal Investigator: Mette Elise Estensen, MD., PhD, ProCardio, Kardiologisk avdeling Rikshospitalet, Oslo Univeristy Hospital

Publications and helpful links

Helpful Links

• ProCardio Home site
• NOR-SCAD

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: SCAD NORGE; NOR-SCAD; Spontan Koronar arteriedisseksjon studie; Norwegian Spontaneous Coronary artery dissection study
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction
• Other Study ID Numbers: 853139; ProCardio (Other Identifier: Oslo University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No