NCT07526766 · Mayo Clinic
A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia
What this study is about
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).
View original scientific description
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).
Interventions
BEHAVIORAL
Aerobic and resistance exercises
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 outcome measures
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
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.
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Jacksonville, Florida
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations