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)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Spontaneous Coronary Artery Dissection
• Intervention / Treatment: Other: Arterial Tonometry; Diagnostic test: Echocardiogram; Diagnostic test: Carotid Ultrasounds; Diagnostic test: Elastography; Other: Ankle-Brachial Index; Other: Microneurography with sympathoexcitatory maneuvers

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pamela Engrav; Phone Number: 507-255-6938; Email: Engrav.Pamela@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Spontaneous coronary artery dissection (SCAD) group; Subject with a history of SCAD will undergo a series of diagnostic studies to assess neurovascular function.	Other: Arterial Tonometry; We will measure arterial stiffness using arterial tonometry.; Diagnostic test: Echocardiogram; We will collect limited ultrasound images of the heart.; Diagnostic test: Carotid Ultrasounds; We will perform ultrasound imaging of the carotid artery.; Diagnostic test: 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.; Other: 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.
Other: Healthy Control Group; Healthy subjects will undergo a series of diagnostic studies to assess neurovascular function.	Other: Arterial Tonometry; We will measure arterial stiffness using arterial tonometry.; Diagnostic test: Echocardiogram; We will collect limited ultrasound images of the heart.; Diagnostic test: Carotid Ultrasounds; We will perform ultrasound imaging of the carotid artery.; Diagnostic test: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Marysia Tweet, MD, MS, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Coronary Vessel Anomalies; Aortic Dissection
• Other Study ID Numbers: 21-005636; 1K23HL155506 (U.S. NIH Grant/Contract)

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