SCADNOR-SCADNCT07317323
Norwegian Spontaneous Coronary Artery Dissection Study
An observational study of SCAD and Myocardial Infarction (MI), run by Oslo University Hospital at 3 sites in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCAD, Myocardial Infarction (MI), Women
- How many people
- 300 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Apr 2025to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spontaneous coronary artery dissection
Who may be able to join
- Spontaneous coronary artery dissection
Who cannot join
- Severe kidney failure
- Severe allergic reaction to contrast
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway3 sites, 3 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Nigussie Bogale, MD, PhD, +47 413 09 313, nigussie.bogale@lyse.net
- Recruiting
Akershus University Hospital
Oslo
Oliver Meyerdierks, MD, PhD, +47 95975609, oliver.meyerdierks@ahus.no
- Recruiting
Rikshospitalet, Oslo University Hospital
Oslo
Anna Louise Astad Sørlie, MD, +47 92655483, anloso@ous-hf.no
About this study
Official title: 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).
Read the 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:
- 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.
- Conditions
- SCAD, Myocardial Infarction (MI), Women
- Keywords
- SCAD NORGE, NOR-SCAD, Spontan Koronar arteriedisseksjon studie, Norwegian Spontaneous Coronary artery dissection study
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | SCAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events
Recurrent myocardial infarction, extra coronary dissection, stroke/TIA, heart failure,
Measured: From enrollment to the end of follow-up at 52 weeks
Secondary outcomes (2)
Assessment of Quality of life
Quality of life assessed by questionnaire WHO-BREF
Measured: 12 weeks after event
CTA
Computed tomography angiography (CTA) findings
Measured: Acute and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCADStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Haukeland University Hospital, Bergen, Norway, Sorlandet Hospital HF, Universitetssykehuset i Nord-Norge HF, Ullevaal University Hospital, Helse Stavanger HF, St. Olavs Hospital
- Responsible party
- Principal investigator, Mette-Elise Estensen, Oslo University Hospital
- Investigators
- Mette Elise Estensen, MD., PhD, Principal investigator, ProCardio, Kardiologisk avdeling Rikshospitalet, Oslo Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317323
- Sponsor's protocol ID
- 853139
- Other IDs
- ProCardio
- Acronym
- NOR-SCAD
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Spontaneous Coronary Artery Dissection Study (NOR-SCAD Study)
- ClinicalTrials.gov ID
- NCT07317323
- Acronym / sponsor ID
- NOR-SCAD / 853139
- Conditions
- SCAD, Myocardial Infarction (MI), Women
- Keywords
- SCAD NORGE, NOR-SCAD, Spontan Koronar arteriedisseksjon studie, Norwegian Spontaneous Coronary artery dissection study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Haukeland University Hospital, Bergen, Norway, Sorlandet Hospital HF, Universitetssykehuset i Nord-Norge HF, Ullevaal University Hospital, Helse Stavanger HF, St. Olavs Hospital
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | –SCAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spontaneous coronary artery dissection
Key inclusion criteria (1 listed)
- Spontaneous coronary artery dissection
Key exclusion criteria (2 listed)
- Severe kidney failure
- Severe allergic reaction to contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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,
2 secondary outcomes
Assessment of Quality of life
Time frame: 12 weeks after event
CTA
Time frame: Acute and after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- ProCardio Home siteLink provided by the sponsor.
- NOR-SCADLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for SCAD
Not yet recruitingPhase 4
Spontaneous Coronary Artery Dissection - AntipLatelet Therapy Intensity in Guided coNservative Management (SCAD-ALIGN) Trial
SCAD, ACS (Acute Coronary Syndrome)
Enrolling by invitationObservational study
Spontaneous Coronary Artery Dissection (SCAD) Avatar Study
Spontaneous Coronary Artery Dissection
Enrolling by invitation
Norwegian Danish Spontaneous Coronary Artery Dissection Exercise Study
Spontaneous Coronary Artery Dissection, Myocardial Infarction (MI)
Recruiting
A Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection
Spontaneous Coronary Artery Dissection, Healthy
Active, not recruitingObservational study
International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry
Spontaneous Coronary Artery Dissection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mette Elise Estensen, MD., PhD principal investigator
ProCardio, Kardiologisk avdeling Rikshospitalet, Oslo Univeristy Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCAD and Myocardial Infarction (MI), run by Oslo University Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Louise Astad Sørlie, MD (+47 926 55 483, anloso@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: From enrollment to the end of follow-up at 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.