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Norwegian Spontaneous Coronary Artery Dissection Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07317323
Acronym
NOR-SCAD
Enrollment
300
Registered
2026-01-05
Start date
2025-04-01
Completion date
2035-12-31
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction (MI), SCAD, Women

Keywords

SCAD NORGE, NOR-SCAD, Spontan Koronar arteriedisseksjon studie, Norwegian Spontaneous Coronary artery dissection study

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.

Interventions

None listed

Sponsors

University Hospital, Akershus
CollaboratorOTHER
Haukeland University Hospital, Bergen, Norway
CollaboratorUNKNOWN
Sorlandet Hospital HF
CollaboratorOTHER_GOV
Universitetssykehuset i Nord-Norge HF
CollaboratorUNKNOWN
Ullevaal University Hospital
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
St.Olavs Hospital, Trondheim University Hospital, Norway
CollaboratorUNKNOWN
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Spontaneous coronary artery dissection

Exclusion criteria

* Severe kidney failure * Severe allergic reaction to contrast

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiac EventsFrom enrollment to the end of follow-up at 52 weeksRecurrent myocardial infarction, extra coronary dissection, stroke/TIA, heart failure,

Secondary

MeasureTime frameDescription
Assessment of Quality of life12 weeks after eventQuality of life assessed by questionnaire WHO-BREF
CTAAcute and after 12 weeksComputed tomography angiography (CTA) findings

Countries

Norway

Contacts

Primary ContactAnna Louise Astad Sørlie, MD
anloso@ous-hf.no+47 926 55 483

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026