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Recruiting NCT07317323

Norwegian Spontaneous Coronary Artery Dissection Study

Observational SCAD Myocardial Infarction (MI) Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: SCAD, Myocardial Infarction (MI), Women. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Major Adverse Cardiac Events [Time frame: From enrollment to the end of follow-up at 52 weeks]
Secondary outcome measures (2)
  • Assessment of Quality of life [Time frame: 12 weeks after event]
  • CTA [Time frame: Acute and after 12 weeks]

Eligibility criteria

Inclusion criteria

  • Spontaneous coronary artery dissection

Exclusion criteria

  • Severe kidney failure
  • Severe allergic reaction to contrast

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Norway · 3 centers
  • Haukeland University Hospital — Bergen
  • Akershus University Hospital — Oslo
  • Rikshospitalet, Oslo University Hospital — Oslo

Identifiers

NCT: NCT07317323 · 853139 · ProCardio

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗