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

NCT07526766 | Recruiting

• 1 other identifier: 25-011057
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Fibromuscular Dysplasia; Spontaneous Coronary Artery Dissection

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Aerobic and resistance exercise

EXPERIMENTAL

Patients with a history of Spontaneous Coronary Artery Dissection and/or Fibromuscular Dysplasia will undergo three exercise tests.

Behavioral: Aerobic and resistance exercises

Interventions

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

Aerobic and resistance exercise

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fibromuscular Dysplasia; Coronary Artery Dissection, Spontaneous

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elizabeth H. Dineen, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armia R. Habil, MD

CONTACT

904-953-0859; habil.armia@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)