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NCT Number: NCT06601270

SCAD : a Registry of Spontaneous Coronary Artery Dissection

Spontaneous coronary artery dissection (SCAD) is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes (ACS), predominantly afflicting young women without conventional atherosclerotic risk factors. Knowledge of SCAD has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6. Like all rarer diseases however, a better understanding of SCAD will require international collaboration. At present, there is no European or International SCAD registry despite increasing recognition that there are key differences in the diagnosis, interventional and medical management of SCAD compared with conventional atherosclerotic ACS. The ESC-ACCA Study Group on Spontaneous Coronary Artery Dissection supported by the European Observational Research Programme will now build the first pan-European SCAD registry to advance our understanding of current management of this condition, inform guidelines, educate clinical colleagues and advance research.

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Key information

Conditions

Spontaneous Coronary Artery Dissection Coronary Artery Dissection, Spontaneous

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ICBA - Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina

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About this study

Observational, multicentre, international retrospective and prospective cohort study.

Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled.

Patient data will be collected at the following time-points:

  • First SCAD event visit (retrospectively on chart review)
  • First follow-up: at time of enrolment
  • Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion

Approximately 30 countries and 120 sites will participate in this registry.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient having signed an Informed Consent
  • Patient aged 18 years and over
  • SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery

Exclusion criteria

  • Patient unwilling or unable to consent
  • Patients with iatrogenic or atherosclerotic coronary dissection

Treatment and study plan

There are no interventions as the study is purely observational.

Other

There are no interventions as the study is purely observational.

Primary outcomes

  1. Patient Status:

    Time frame: Up to 5 years post-enrollment

    • Measure: Functional health status and clinical condition during follow-up.
    • Unit of Measure: Categorized as stable, improved, or worsened.

  2. Vital Signs:

    Time frame: Up to 5 years post-enrollment

    -Heart Rate: Measure: Heart rate monitoring. Unit of Measure: Beats per minute (bpm).

    -Blood Pressure: Measure: Systolic and diastolic blood pressure measurement. Unit of Measure: Millimeters of mercury (mmHg).

    -Oxygen Saturation: Measure: Oxygen saturation monitoring. Unit of Measure: Percentage (%).

  3. Recurrent SCAD Events:

    Time frame: Up to 5 years post-enrollment

    • Measure: Documentation of recurrent SCAD events, including clinical presentation, diagnosis, management, and procedures.
    • Unit of Measure: Number of recurrent SCAD events.

  4. Imagery:

    Time frame: Up to 5 years post-enrollment

    • Measure: Coronary angiography anonymized and sent for central review (Corelab) for confirmation and analysis.
    • Unit of Measure: Yes/No (whether imagery was obtained and sent).

  5. Medications:

    Time frame: Up to 5 years post-enrollment

    Antiplatelet Medications:

    • Measure: Use of antiplatelet medications during follow-up. Unit of Measure: Number of antiplatelet medications prescribed.
    • Beta-Blockers:

    Measure: Use of beta-blocker medications during follow-up. Unit of Measure: Number of beta-blockers prescribed.

    -ACE Inhibitors/ARBs: Measure: Use of ACE inhibitors or angiotensin receptor blockers (ARBs) during follow-up.

    Unit of Measure: Number of ACE inhibitors/ARBs prescribed.

    -Calcium Channel Blockers: Measure: Use of calcium channel blockers during follow-up. Unit of Measure: Number of calcium channel blockers prescribed.

    -Statins: Measure: Use of statin medications during follow-up. Unit of Measure: Number of statins prescribed.

    -Other Medications (if applicable): Measure: Use of other medication classes during follow-up. Unit of Measure: Number and type of additional medications prescribed.

  6. Menstrual, Contraceptive, and Obstetric History:

    Time frame: Up to 5 years post-enrollment

    • Measure: Menstrual status, use of contraceptives, and obstetric history during follow-up.
    • Unit of Measure: Categorical variables (e.g., premenopausal, postmenopausal; use of contraceptives: Yes/No).

  7. Discharge Information:

    Time frame: Up to 5 years post-enrollment

    • Measure: Discharge status following SCAD-related hospital admissions.
    • Unit of Measure: Categorical variables (e.g., discharged to home, transferred to rehabilitation).

Secondary outcomes

  1. Procedures:

    Time frame: Up to 5 years post-enrollment

    • Measure: Documentation of any medical or surgical procedures related to SCAD during follow-up (e.g., coronary interventions).
    • Unit of Measure: Number of procedures.

  2. Other Coronary Vascular Events:

    Time frame: Up to 5 years post-enrollment

    • Measure: Occurrence of any other coronary vascular events (e.g., myocardial infarction, ischemia, revascularization).
    • Unit of Measure: Number of events.

  3. Symptomatology:

    Time frame: Up to 5 years post-enrollment

    • Measure: Patient-reported symptoms related to cardiovascular health (e.g., chest pain, dyspnea, palpitations).
    • Unit of Measure: Symptom frequency and severity (scale-based or categorical, e.g., mild, moderate, severe).

  4. Pregnancy and Hormonal Therapy (when applicable):

    Time frame: Up to 5 years post-enrollment

    • Measure: Pregnancy status and use of hormonal therapy during follow-up.
    • Unit of Measure: Categorical variables (e.g., pregnant: Yes/No; hormonal therapy: Yes/No).

  5. Exercise History:

    Time frame: Up to 5 years post-enrollment

    -Exercise Frequency: Measure: Frequency of exercise sessions per week. Unit of Measure: Times per week.

    -Exercise Duration: Measure: Duration of each exercise session. Unit of Measure: Minutes per session.

    -Type of Exercise: Measure: Type of physical activity performed (e.g., aerobic, resistance, flexibility).

    Unit of Measure: Categorical variables (e.g., aerobic, resistance, flexibility).

  6. Mental Health and Wellbeing:

    Time frame: Up to 5 years post-enrollment

    -Anxiety (HADS-A): Measure: Anxiety levels assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A).

    Unit of Measure: HADS-A score (range: 0 to 21; higher scores indicate worse anxiety symptoms).

    -Depression (PHQ-9): Measure: Depression levels assessed using the Patient Health Questionnaire-9 (PHQ-9).

    Unit of Measure: PHQ-9 score (range: 0 to 27; higher scores indicate worse depression symptoms).

    -Overall Wellbeing: Measure: Overall wellbeing rating on a self-reported scale. Unit of Measure: Wellbeing rating score (range: 1 to 10; higher scores indicate better wellbeing).

  7. Employment Post-SCAD:

    Time frame: At first follow-up visit only

    • Measure: Employment status following SCAD event.
    • Unit of Measure: Categorical variables (e.g., employed, unemployed, part-time).

Study contacts

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

Adham GHARIEB, PharmD

CONTACT

[email protected]

048-388-1770

Gabrielle BONNEVILLE

CONTACT

[email protected]

048-987-2082

Sponsors and collaborators

Lead sponsor

European Society of Cardiology

Network

Registry information

Official study title

A Registry of Spontaneous Coronary Artery Dissection

Acronym: SCAD

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Oct 29, 2024

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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