A Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection
Role of the Neurovascular System in Spontaneous Coronary Artery Dissection (SCAD)
2 other identifiers
interventional
50
1 country
1
Brief Summary
The purpose of this research is to compare sympathetic function (flight or fight system) and arterial health including structure and mechanics of participants with history of spontaneous coronary artery dissection (SCAD) to age and sex matched control participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
June 12, 2025
June 1, 2025
4.2 years
January 16, 2023
June 10, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Arterial thickness
Measured by carotid ultrasound intimal media thickness reporting in mm
Baseline
Arterial stiffness
Measured by carotid ultrasound pulse wave velocity reporting in m/s
Baseline
Baroreflex sensitivity
The slope between heart rate and blood pressure at rest and during the Valsalva Maneuver (ms/mmHg)
Baseline
Sympathetic response to stress
Blood pressure or muscle sympathetic nerve activity response to sympathoexcitatory stressors (mm/Hg or bursts/min).
Baseline
Study Arms (2)
Spontaneous coronary artery dissection (SCAD) group
OTHERSubject with a history of SCAD will undergo a series of diagnostic studies to assess neurovascular function.
Healthy Control Group
OTHERHealthy subjects will undergo a series of diagnostic studies to assess neurovascular function.
Interventions
We will measure arterial stiffness using arterial tonometry.
We will collect limited ultrasound images of the heart.
We will perform ultrasound imaging of the carotid artery.
We will measure the elastic properties of the arteries using elastography.
We will measure the ankle-brachial index to assess peripheral artery blood flow.
We will measure sympathetic nerve activity at rest and in response to isometric handgrip, mental stress test, cold pressor test, Valsalva maneuvers.
Eligibility Criteria
You may qualify if:
- For SCAD patients: history of SCAD as confirmed by coronary angiography or cardiac computed tomography angiography
- For controls: no cardiac disease history
You may not qualify if:
- Pregnancy
- Known or suspected unstable cardiac condition within 4 weeks of the study
- Active treatment with anticoagulation or dual antiplatelet therapy
- Prisoner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marysia Tweet, MD, MS
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 16, 2023
First Posted
January 26, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share