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

Primary Purpose

Spontaneous Coronary Artery Dissection, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial Tonometry
Echocardiogram
Carotid Ultrasounds
Elastography
Ankle-Brachial Index
Microneurography with sympathoexcitatory maneuvers
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Spontaneous Coronary Artery Dissection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Spontaneous coronary artery dissection (SCAD) group

Healthy Control Group

Arm Description

Subject with a history of SCAD will undergo a series of diagnostic studies to assess neurovascular function.

Healthy subjects will undergo a series of diagnostic studies to assess neurovascular function.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2023
Last Updated
June 5, 2023
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05699200
Brief Title
A Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection
Official Title
Role of the Neurovascular System in Spontaneous Coronary Artery Dissection (SCAD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Coronary Artery Dissection, Healthy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spontaneous coronary artery dissection (SCAD) group
Arm Type
Other
Arm Description
Subject with a history of SCAD will undergo a series of diagnostic studies to assess neurovascular function.
Arm Title
Healthy Control Group
Arm Type
Other
Arm Description
Healthy subjects will undergo a series of diagnostic studies to assess neurovascular function.
Intervention Type
Other
Intervention Name(s)
Arterial Tonometry
Intervention Description
We will measure arterial stiffness using arterial tonometry.
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiogram
Intervention Description
We will collect limited ultrasound images of the heart.
Intervention Type
Diagnostic Test
Intervention Name(s)
Carotid Ultrasounds
Intervention Description
We will perform ultrasound imaging of the carotid artery.
Intervention Type
Diagnostic Test
Intervention Name(s)
Elastography
Intervention Description
We will measure the elastic properties of the arteries using elastography.
Intervention Type
Other
Intervention Name(s)
Ankle-Brachial Index
Intervention Description
We will measure the ankle-brachial index to assess peripheral artery blood flow.
Intervention Type
Other
Intervention Name(s)
Microneurography with sympathoexcitatory maneuvers
Intervention Description
We will measure sympathetic nerve activity at rest and in response to isometric handgrip, mental stress test, cold pressor test, Valsalva maneuvers.
Primary Outcome Measure Information:
Title
Arterial thickness
Description
Measured by carotid ultrasound intimal media thickness reporting in mm
Time Frame
Baseline
Title
Arterial stiffness
Description
Measured by carotid ultrasound pulse wave velocity reporting in m/s
Time Frame
Baseline
Title
Baroreflex sensitivity
Description
The slope between heart rate and blood pressure at rest and during the Valsalva Maneuver (ms/mmHg)
Time Frame
Baseline
Title
Sympathetic response to stress
Description
Blood pressure or muscle sympathetic nerve activity response to sympathoexcitatory stressors (mm/Hg or bursts/min).
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Engrav
Phone
507-255-6938
Email
Engrav.Pamela@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marysia Tweet, MD, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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