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NCT Number: NCT07526766

A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia

The purpose of this study is to assess the cardiopulmonary, hemodynamic, and symptom responses to acute bouts of varying intensity aerobic and resistance exercise in people with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD).

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Key information

Conditions

Fibromuscular Dysplasia Arterial Occlusive Diseases Cardiovascular Diseases Coronary Artery Dissection, Spontaneous Spontaneous Coronary Artery Dissection Vascular Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Armia R. Habil, MD

CONTACT

[email protected]

904-953-0859

Elizabeth H. Dineen, DO

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD), ≥2 months post-event, and free from chest pain.
  • Able to provide written informed consent

Exclusion criteria

  • Individuals who are clinically obese (BMI ≥36) and/or who suffer from musculoskeletal or other conditions that would limit exercise participation.
  • Individuals who are deemed medically unstable
  • Participants who are unable to comply with study requirements.
  • Pregnancy

Treatment and study plan

Aerobic and resistance exercises

Behavioral

Subjects will undergo three exercise tests, each separated by at least 48 hours:

  • Symptom-limited cardiopulmonary exercise test (CPET): Patients will cycle upright starting at 0W (3 min) before the workload is increased by 10-35W·min-1 in a ramp fashion (like cycling up a progressively steeper hill) until volitional exhaustion for the determination of V̇O2peak and Wpeak
  • Two-stage submaximal constant power exercise test: Following a 5-minute warm-up (10-20 W), participants will cycle in the moderate intensity domain for 25 minutes followed by 25 minutes in the heavy intensity domain.
  • Six different resistance exercises of varying intensities: Participants will perform three sets of six different resistance exercises: chest press; lateral raises; abdominal crunches; planks; leg press; weighted lunges

Primary outcomes

  1. Change in blood pressure in response to aerobic exercise

    Time frame: Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes

    Systemic blood pressure will be measured at rest, at peak exercise, and for 5 minutes of recovery after exercise via finger photoplethysmography and reported as mmHg

  2. Dartmouth COOP Functional Assessment Chart score

    Time frame: Baseline

    The Dartmouth COOP Functional Assessment Charts are a set of patient-reported, pictorial tools used to measure physical, mental, and social functioning. The tool includes 9 questions that are rated on scores from 1-5, with higher scores indicating worse function.

  3. Duke Activity Index Status (DASI) score

    Time frame: Baseline

    The Duke Activity Status Index (DASI) is a self-administered questionnaire that measures a patient's functional capacity. It consists of 12 yes/no questions. Scores range from 0 to 58.2, with higher scores indicating better exercise capacity.

  4. International Physical Activity Questionnaire Short Form (IPAQ-SF) score

    Time frame: Baseline

    The International Physical Activity Questionnaire Short Form (IPAQ-SF) is a 7-item self-reported questionnaire where subjects report time spent being physically active in the last 7 days reported hours per day or minutes per day.

  5. Change in perceived exertion

    Time frame: Baseline, 25 minutes, and 50 minutes

    Perceived exertion (breathlessness and leg fatigue) will be obtained using the Borg 0-10 scale.

  6. Change in blood lactate concentration [La-]b

    Time frame: Baseline, 25 minutes, and 50 minutes

    Blood lactate concentration [La-]b will be measured via analysis of a pinprick point-of-care lactate test (via the earlobe) at rest, during exercise, and at peak exercise.

Study contacts

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

Armia R. Habil, MD

CONTACT

[email protected]

904-953-0859

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Cardiopulmonary, Hemodynamic, And Symptom Responses To Aerobic And Resistance Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia: A Single-center, Single-arm Prospective Clinical Trial.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Jul 10, 2026

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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