NCT07317323

Norwegian Spontaneous Coronary Artery Dissection Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-04-01
• Primary completion: 2035-12-31
• Completion: 2035-12-31
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

3 sites across 1 country: Norway