NCT05699200

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2023Aug 2027

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

4.2 years

First QC Date

January 16, 2023

Last Update Submit

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

OTHER

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

Other: Arterial TonometryDiagnostic Test: EchocardiogramDiagnostic Test: Carotid UltrasoundsDiagnostic Test: ElastographyOther: Ankle-Brachial IndexOther: Microneurography with sympathoexcitatory maneuvers

Healthy Control Group

OTHER

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

Other: Arterial TonometryDiagnostic Test: EchocardiogramDiagnostic Test: Carotid UltrasoundsDiagnostic Test: ElastographyOther: Ankle-Brachial IndexOther: Microneurography with sympathoexcitatory maneuvers

Interventions

We will measure arterial stiffness using arterial tonometry.

Healthy Control GroupSpontaneous coronary artery dissection (SCAD) group
EchocardiogramDIAGNOSTIC_TEST

We will collect limited ultrasound images of the heart.

Healthy Control GroupSpontaneous coronary artery dissection (SCAD) group
Carotid UltrasoundsDIAGNOSTIC_TEST

We will perform ultrasound imaging of the carotid artery.

Healthy Control GroupSpontaneous coronary artery dissection (SCAD) group
ElastographyDIAGNOSTIC_TEST

We will measure the elastic properties of the arteries using elastography.

Healthy Control GroupSpontaneous coronary artery dissection (SCAD) group

We will measure the ankle-brachial index to assess peripheral artery blood flow.

Healthy Control GroupSpontaneous coronary artery dissection (SCAD) group

We will measure sympathetic nerve activity at rest and in response to isometric handgrip, mental stress test, cold pressor test, Valsalva maneuvers.

Healthy Control GroupSpontaneous coronary artery dissection (SCAD) group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous

Interventions

EchocardiographyUltrasonography, Carotid ArteriesElasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Marysia Tweet, MD, MS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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

Locations