Norwegian Danish Spontaneous Coronary Artery Dissection Exercise Study

Condition(s) studied

Investigational drug(s) / intervention(s)

High intensity interval training (HIIT): Participants take part in a supervised treadmill-based high-intensity interval training program twice per week for 12 weeks. Each session is 4 minutes x 4 at target heart rate between 85-95% of maximum HR.

Study summary

The goal of this randomized clinical trial is to determine whether a supervised high-intensity interval training (HIIT) program can safely improve cardiorespiratory fitness and overall health in adults who have previously had spontaneous coronary artery dissection (SCAD), a non-atherosclerotic cause of heart attack that often affects younger women.

Participants are women and men aged 18 years or older, with a confirmed SCAD at least 12 weeks before enrollment, who are medically stable, cleared for exercise testing, and able to attend supervised sessions.

The main questions the study aims to answer are:

* Does a 12-week supervised HIIT program lead to a greater improvement in cardiorespiratory fitness (measured as peak oxygen uptake (VO2peak, ml/kg/min)) compared with usual care, without increasing the occurrence of major adverse cardiovascular events (MACE)?
* Is a 12-week HIIT program safe for people with prior SCAD, assessed by the occurrence of MACE?

Researchers will compare two randomized groups (1:1):

* Group A (HIIT): Participants take part in a supervised treadmill-based high-intensity interval training program twice per week for 12 weeks, with continuous heart rate monitoring and clear rules for stopping in case of symptoms.
* Group B (usual care): Participants continue with the exercise advice they have already received after SCAD, without a structured supervised program and with a recommendation to avoid high-intensity exercise (above 85% of maximum heart rate).

Participants in both groups will:

* Undergo cardiopulmonary exercise testing (CPET) at baseline and after 12 weeks to measure VO2peak and blood pressure response during exercise.
* Have blood tests (for example cholesterol and cardiac biomarkers), blood pressure, heart rate and weight measured.
* Complete validated questionnaires on quality of life (World Health Organization Quality of Life-BREF (WHOQOL-BREF)), anxiety (Generalized Anxiety Disorder 7-item scale (GAD-7)), and depression (Patient Health Questionnaire-9 (PHQ-9)).
* Have activity data recorded using the MIA activity-tracking app and heart rate data will be uploaded simultaneously from portable devices.

Safety will be monitored continuously. Major adverse cardiovascular events (MACE), including death, recurrent heart attack (SCAD or non-SCAD), heart failure, stroke or transient ischemic attack, extracoronary arterial dissection, cardioversion or implantable cardioverter-defibrillator (ICD) therapy, will be recorded during the 12-week intervention and a 25-week follow-up period (total study duration per participant: 37 weeks).

Eligibility

Primary outcome measure(s)

• Change from baseline to 12 weeks in peak oxygen uptake (VO2peak, ml/kg/min) measured by CPET — From enrollment to the end of intervention (12 weeks)

Trial sites (1)

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