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

September 3, 2026 updated by: Elizabeth H. Dineen, Mayo Clinic

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Elizabeth H. Dineen, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aerobic and resistance exercise
Patients with a history of Spontaneous Coronary Artery Dissection and/or Fibromuscular Dysplasia will undergo three exercise tests.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline, 25 minutes, and 50 minutes
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.
Baseline, 25 minutes, and 50 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth H. Dineen, DO, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-011057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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