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NCT Number: NCT07317323

Norwegian Spontaneous Coronary Artery Dissection 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).

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Key information

Conditions

SCAD Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Infarction (MI) Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Women

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spontaneous coronary artery dissection

Exclusion criteria

  • Severe kidney failure
  • Severe allergic reaction to contrast

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiac Events

    Time frame: From enrollment to the end of follow-up at 52 weeks

    Recurrent myocardial infarction, extra coronary dissection, stroke/TIA, heart failure,

Secondary outcomes

  1. Assessment of Quality of life

    Time frame: 12 weeks after event

    Quality of life assessed by questionnaire WHO-BREF

  2. CTA

    Time frame: Acute and after 12 weeks

    Computed tomography angiography (CTA) findings

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Louise Astad Sørlie, MD

CONTACT

[email protected]

+47 926 55 483

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Haukeland University Hospital, Bergen, Norway
  • Helse Stavanger HF
  • Sorlandet Hospital HF
  • St. Olavs Hospital
  • Ullevaal University Hospital
  • Universitetssykehuset i Nord-Norge HF
  • University Hospital, Akershus

Registry information

Official study title

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

Acronym: NOR-SCAD

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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