Norwegian Danish Spontaneous Coronary Artery Dissection Exercise Study

NCT07785765 | Enrolling By Invitation DMC

• 1 other identifier: REKnr 975719
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Spontaneous Coronary Artery Dissection; Myocardial Infarction (MI); High Intensity Interval Training

Keywords

SCAD; Exercise; HIIT; MACE; Spontaneous coronary artery dissection; High intensity interval training

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• MACE (composite of recurrent SCAD, TIA/stroke, extra-coronary artery dissection,death and/or aborted cardiac arrest)

  From enrollment to end of follow-up period (12 weeks + 25 weeks)

• Incidence of MACE (recurrent SCAD alone)

  From enrollment to end of follow-up period (12 weeks + 25 weeks)

• Incidence of MACE (death or aborted cardiac arrest)

  From enrollment to end of follow-up period (12 weeks + 25 weeks)

• Change in quality of life

  From enrollment to end of intervention (12 weeks)

• Change in depression

  From enrollment to end of intervention (12 weeks)

Study Arms (2)

Group A - High intensity interval training (HIIT)

EXPERIMENTAL

Intervention

Other: High intensity interval training (HIIT)

Group B - Usual Care

NO INTERVENTION

Usual care with exercise restriction

Interventions

High intensity interval training (HIIT) OTHER

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.

Group A - High intensity interval training (HIIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed SCAD, at least 12 weeks since last event, age 18 years or older, medically stable and cleared for CPET and supervised exercise

You may not qualify if:

• Disease with exercise restrictions, exercise related severe hypertension on CPET (\>220 mmHg in Systolic blood pressure or \>110mmHg in Diastolic blood pressure)

Sponsors & Collaborators

• Oslo University Hospital: lead
• Clinical Trial Unit (CTU), Oslo University Hospital: collaborator
• University of Oslo: collaborator

Study Sites (1)

Rikshospitalet, Department of Cardiology, ProCardio Center for Innovation

Oslo, 0372, Norway

Location

Related Publications (12)

• Hilton SE, Thiessen JS, Rycroft AD, Miners NI, Bommarito JC, Matharu TS, Khangura PK, Stapleton RK, Rocha LC, Nardone M, Millar PJ. Influence of sex and aerobic fitness on blood pressure during maximal treadmill exercise in young healthy adults. J Appl Physiol (1985). 2025 Jun 1;138(6):1321-1326. doi: 10.1152/japplphysiol.00056.2025. Epub 2025 May 5.

  PMID: 40323584 BACKGROUND

• Schultz MG, Otahal P, Roberts-Thomson P, Stanton T, Hamilton-Craig C, Wahi S, La Gerche A, Hare JL, Selvanayagam J, Maiorana A, Venn AJ, Marwick TH, Sharman JE. Exercise blood pressure relative to fitness and cardiovascular outcomes: the EXERTION study. Eur Heart J. 2026 Apr 7;47(14):1661-1671. doi: 10.1093/eurheartj/ehaf1082.

  PMID: 41528824 BACKGROUND

• De Backer J, Haugaa KH, Hasselberg NE, de Hosson M, Brida M, Castelletti S, Cauldwell M, Cerbai E, Crotti L, de Groot NMS, Estensen ME, Goossens ES, Haring B, Kurpas D, McEniery CM, Peters SAE, Rakisheva A, Sambola A, Schlager O, Schoenhoff FS, Simoncini T, Steinbach F, Sudano I, Swan L, Valente AM; ESC Scientific Document Group. 2025 ESC Guidelines for the management of cardiovascular disease and pregnancy. Eur Heart J. 2025 Nov 14;46(43):4462-4568. doi: 10.1093/eurheartj/ehaf193. No abstract available.

  PMID: 40878294 BACKGROUND

• Heath A, Offringa M, Pechlivanoglou P, Rios JD, Klassen TP, Poonai N, Pullenayegum E; KidsCAN PERC Innovative Paediatric Clinical Trials Team. Determining a Bayesian predictive power stopping rule for futility in a non-inferiority trial with binary outcomes. Contemp Clin Trials Commun. 2020 Apr 8;18:100561. doi: 10.1016/j.conctc.2020.100561. eCollection 2020 Jun.

  PMID: 32300671 BACKGROUND

• Tucker WJ, Fegers-Wustrow I, Halle M, Haykowsky MJ, Chung EH, Kovacic JC. Exercise for Primary and Secondary Prevention of Cardiovascular Disease: JACC Focus Seminar 1/4. J Am Coll Cardiol. 2022 Sep 13;80(11):1091-1106. doi: 10.1016/j.jacc.2022.07.004.

  PMID: 36075680 BACKGROUND

• Kavanagh T, Mertens DJ, Hamm LF, Beyene J, Kennedy J, Corey P, Shephard RJ. Peak oxygen intake and cardiac mortality in women referred for cardiac rehabilitation. J Am Coll Cardiol. 2003 Dec 17;42(12):2139-43. doi: 10.1016/j.jacc.2003.07.028.

  PMID: 14680741 BACKGROUND

• Stensvold D, Viken H, Steinshamn SL, Dalen H, Stoylen A, Loennechen JP, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Sandbakk SB, Carlsen T, Ingebrigtsen JE, Lydersen S, Mattsson E, Anderssen SA, Fiatarone Singh MA, Coombes JS, Skogvoll E, Vatten LJ, Helbostad JL, Rognmo O, Wisloff U. Effect of exercise training for five years on all cause mortality in older adults-the Generation 100 study: randomised controlled trial. BMJ. 2020 Oct 7;371:m3485. doi: 10.1136/bmj.m3485.

  PMID: 33028588 BACKGROUND

• Mueller S, Winzer EB, Duvinage A, Gevaert AB, Edelmann F, Haller B, Pieske-Kraigher E, Beckers P, Bobenko A, Hommel J, Van de Heyning CM, Esefeld K, von Korn P, Christle JW, Haykowsky MJ, Linke A, Wisloff U, Adams V, Pieske B, van Craenenbroeck EM, Halle M; OptimEx-Clin Study Group. Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2021 Feb 9;325(6):542-551. doi: 10.1001/jama.2020.26812.

  PMID: 33560320 BACKGROUND

• Battenberg AE, Carey P, Larson KF, Hayes SN, Smith JR, Baker SE, Bonikowske AR, Tweet MS. Spontaneous Coronary Artery Dissection in Highly Active Individuals: Insights From a Prospective Registry. JACC Adv. 2026 Feb;5(2):102485. doi: 10.1016/j.jacadv.2025.102485. Epub 2026 Jan 2.

  PMID: 41483544 BACKGROUND

• Chacin-Suarez AS, Bonikowske AR, Medina-Inojosa JR, Gulati R, Best PJ, Hayes SN, Tweet MS. Physical Activity and Exercise Patterns After Spontaneous Coronary Artery Dissection: Insights From a Large Multinational Registry. Front Cardiovasc Med. 2021 Jun 15;8:642739. doi: 10.3389/fcvm.2021.642739. eCollection 2021.

  PMID: 34212011 BACKGROUND

• Kim SK, Wing-Lun E, Chandrasekhar J, Puri A, Burgess S, Ford TJ, Kovacic J, Graham RM, Psaltis PJ, Zaman S. The Australian New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry - A Multi-Centre Cohort Study: Protocol, Background and Significance. Heart Lung Circ. 2022 Dec;31(12):1612-1618. doi: 10.1016/j.hlc.2022.08.018. Epub 2022 Sep 28.

  PMID: 36180304 BACKGROUND

• Saw J, Starovoytov A, Aymong E, Inohara T, Alfadhel M, McAlister C, Samuel R, Grewal T, Parolis JA, Sheth T, So D, Minhas K, Brass N, Lavoie A, Bishop H, Lavi S, Pearce C, Renner S, Madan M, Welsh RC, McGrath BM, Vijayaraghavan R, Har B, Ibrahim R, Chaudhary P, Ganesh SK, Graham J, Matteau A, Martucci G, Ko DT, Humphries K, Mancini GJ. Canadian Spontaneous Coronary Artery Dissection Cohort Study: 3-Year Outcomes. J Am Coll Cardiol. 2022 Oct 25;80(17):1585-1597. doi: 10.1016/j.jacc.2022.08.759.

  PMID: 36265953 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Myocardial Infarction; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kristina Hermann Haugaa, Phd

  Rikshospitalet, Oslo Univeristy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)