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

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: Recruiting
• Conditions: Spontaneous Coronary Artery Dissection; Fibromuscular Dysplasia
• Intervention / Treatment: Behavioral: Aerobic and resistance exercises

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armia R. Habil, MD; Phone Number: 904-953-0859; Email: habil.armia@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Armia R. Habil, MD; Phone Number: 904-953-0859; Email: habil.armia@mayo.edu
      • Principal Investigator: Elizabeth H. Dineen, DO

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	Baseline
Change in perceived exertion	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	Blood lactate concentration [La-]b will be measured via analysis of a pinprick point-of-care lactate test (via the earlobe) at rest, every 2 minutes during exercise, and at peak exercise.	Baseline, 25 minutes, and 50 minutes

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Elizabeth H. Dineen, DO, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Fibromuscular Dysplasia; Coronary Artery Dissection, Spontaneous
• Other Study ID 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