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

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05699200
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
50
1
2
53.9
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Arterial Tonometry
  • Diagnostic Test: Echocardiogram
  • Diagnostic Test: Carotid Ultrasounds
  • Diagnostic Test: Elastography
  • Other: Ankle-Brachial Index
  • Other: Microneurography with sympathoexcitatory maneuvers
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Role of the Neurovascular System in Spontaneous Coronary Artery Dissection (SCAD)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Arterial thickness [Baseline]

    Measured by carotid ultrasound intimal media thickness reporting in mm

  2. Arterial stiffness [Baseline]

    Measured by carotid ultrasound pulse wave velocity reporting in m/s

  3. Baroreflex sensitivity [Baseline]

    The slope between heart rate and blood pressure at rest and during the Valsalva Maneuver (ms/mmHg)

  4. Sympathetic response to stress [Baseline]

    Blood pressure or muscle sympathetic nerve activity response to sympathoexcitatory stressors (mm/Hg or bursts/min).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Marysia Tweet, MD, MS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Marysia Tweet, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05699200
Other Study ID Numbers:
  • 21-005636
  • 1K23HL155506
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023