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NCT05699200 Clinical Trial

A Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection

Healthy Clinical Trial

Official title:
Role of the Neurovascular System in Spontaneous Coronary Artery Dissection (SCAD)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05699200
Other study ID # 21-005636
Secondary ID 1K23HL155506
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date August 2027

Study information
Verified date June 2024
Source Mayo Clinic
Contact Pamela Engrav
Phone 507-255-6938
Email Engrav.Pamela@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date August 2027
Est. primary completion date August 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - For SCAD patients: history of SCAD as confirmed by coronary angiography or cardiac computed tomography angiography - For controls: no cardiac disease history Exclusion Criteria: - Pregnancy - Known or suspected unstable cardiac condition within 4 weeks of the study - Active treatment with anticoagulation or dual antiplatelet therapy - Prisoner

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Arterial Tonometry
We will measure arterial stiffness using arterial tonometry.
Diagnostic Test:
• Echocardiogram
We will collect limited ultrasound images of the heart.
• Carotid Ultrasounds
We will perform ultrasound imaging of the carotid artery.
• Elastography
We will measure the elastic properties of the arteries using elastography.
Other:
• Ankle-Brachial Index
We will measure the ankle-brachial index to assess peripheral artery blood flow.
• Microneurography with sympathoexcitatory maneuvers
We will measure sympathetic nerve activity at rest and in response to isometric handgrip, mental stress test, cold pressor test, Valsalva maneuvers.

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Arterial thickness Measured by carotid ultrasound intimal media thickness reporting in mm Baseline
Primary Arterial stiffness Measured by carotid ultrasound pulse wave velocity reporting in m/s Baseline
Primary Baroreflex sensitivity The slope between heart rate and blood pressure at rest and during the Valsalva Maneuver (ms/mmHg) Baseline
Primary Sympathetic response to stress Blood pressure or muscle sympathetic nerve activity response to sympathoexcitatory stressors (mm/Hg or bursts/min). Baseline
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