Fibromuscular DysplasiaNCT07526766
A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia
A study testing Aerobic and resistance exercises in people with Fibromuscular Dysplasia and Spontaneous Coronary Artery Dissection, run by Mayo Clinic at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection
- What is being tested?
- Aerobic and resistance exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Armia R. Habil, MD, 904-953-0859, habil.armia@mayo.edu
Elizabeth H. Dineen, DO
About this study
Official 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.
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).
- Being tested
- Aerobic and resistance exercises
- Medical subject headings
- Fibromuscular Dysplasia, Coronary Artery Dissection, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and resistance exercisesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Aerobic and resistance exercise | Experimental | Patients with a history of Spontaneous Coronary Artery Dissection and/or Fibromuscular Dysplasia will undergo three exercise tests. Receives: Behavioral: Aerobic and resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure in response to aerobic exercise
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
Measured: Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes
Dartmouth COOP Functional Assessment Chart score
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.
Measured: Baseline
Duke Activity Index Status (DASI) score
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.
Measured: Baseline
International Physical Activity Questionnaire Short Form (IPAQ-SF) score
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.
Measured: Baseline
Change in perceived exertion
Perceived exertion (breathlessness and leg fatigue) will be obtained using the Borg 0-10 scale.
Measured: Baseline, 25 minutes, and 50 minutes
Change in blood lactate concentration [La-]b
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.
Measured: Baseline, 25 minutes, and 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Sep 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromuscular DysplasiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth H. Dineen, Mayo Clinic
- Investigators
- Elizabeth H. Dineen, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526766
- Sponsor's protocol ID
- 25-011057
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07526766
- Acronym / sponsor ID
- 25-011057
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic and resistance exercise | Experimental | Behavioral: Aerobic and resistance exercisesPatients with a history of Spontaneous Coronary Artery Dissection and/or Fibromuscular Dysplasia will undergo three exercise tests. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic and resistance exercisesSubjects 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 | Behavioural | Aerobic and resistance exercise |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth H. Dineen, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and resistance exercises in people with Fibromuscular Dysplasia and Spontaneous Coronary Artery Dissection, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armia R. Habil, MD (904-953-0859, habil.armia@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure in response to aerobic exercise (time frame: Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.