Spontaneous Coronary Artery DissectionNCT05699200
A Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection
A study testing Arterial Tonometry, Echocardiogram and Carotid Ultrasounds in people with Spontaneous Coronary Artery Dissection and Healthy, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Coronary Artery Dissection, Healthy
- What is being tested?
- Arterial Tonometry, Echocardiogram and Carotid Ultrasounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For SCAD patients: history of SCAD as confirmed by coronary angiography or cardiac computed tomography angiography
- For controls: no cardiac disease history
Who cannot join
- Pregnancy
- Known or suspected unstable cardiac condition within 4 weeks of the study
- Active treatment with anticoagulation or dual antiplatelet therapy
- Prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Spontaneous Coronary Artery Dissection, Healthy
- Being tested
- Arterial Tonometry, Echocardiogram, Carotid Ultrasounds, Elastography, Ankle-Brachial Index
- Medical subject headings
- Coronary Artery Dissection, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial TonometryOther
We will measure arterial stiffness using arterial tonometry.
EchocardiogramDiagnostic test
We will collect limited ultrasound images of the heart.
Carotid UltrasoundsDiagnostic test
We will perform ultrasound imaging of the carotid artery.
ElastographyDiagnostic test
We will measure the elastic properties of the arteries using elastography.
Ankle-Brachial IndexOther
We will measure the ankle-brachial index to assess peripheral artery blood flow.
Microneurography with sympathoexcitatory maneuversOther
We will measure sympathetic nerve activity at rest and in response to isometric handgrip, mental stress test, cold pressor test, Valsalva maneuvers.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous coronary artery dissection (SCAD) group | Other | Subject with a history of SCAD will undergo a series of diagnostic studies to assess neurovascular function. Receives: Other: Arterial Tonometry; Diagnostic Test: Echocardiogram; Diagnostic Test: Carotid Ultrasounds; Diagnostic Test: Elastography; Other: Ankle-Brachial Index; Other: Microneurography with sympathoexcitatory maneuvers |
| Healthy Control Group | Other | Healthy subjects will undergo a series of diagnostic studies to assess neurovascular function. Receives: Other: Arterial Tonometry; Diagnostic Test: Echocardiogram; Diagnostic Test: Carotid Ultrasounds; Diagnostic Test: Elastography; Other: Ankle-Brachial Index; Other: Microneurography with sympathoexcitatory maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial thickness
Measured by carotid ultrasound intimal media thickness reporting in mm
Measured: Baseline
Arterial stiffness
Measured by carotid ultrasound pulse wave velocity reporting in m/s
Measured: Baseline
Baroreflex sensitivity
The slope between heart rate and blood pressure at rest and during the Valsalva Maneuver (ms/mmHg)
Measured: Baseline
Sympathetic response to stress
Blood pressure or muscle sympathetic nerve activity response to sympathoexcitatory stressors (mm/Hg or bursts/min).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jun 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Coronary Artery DissectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marysia Tweet, Mayo Clinic
- Investigators
- Marysia Tweet, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699200
- Sponsor's protocol ID
- 21-005636
- Other IDs
- 1K23HL155506
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Neurovascular System in Spontaneous Coronary Artery Dissection (SCAD)
- ClinicalTrials.gov ID
- NCT05699200
- Acronym / sponsor ID
- 21-005636
- Conditions
- Spontaneous Coronary Artery Dissection, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous coronary artery dissection (SCAD) group | Other | Other: Arterial Tonometry, Diagnostic Test: Echocardiogram, Diagnostic Test: Carotid Ultrasounds, Diagnostic Test: Elastography, Other: Ankle-Brachial Index, Other: Microneurography with sympathoexcitatory maneuversSubject with a history of SCAD will undergo a series of diagnostic studies to assess neurovascular function. |
| Healthy Control Group | Other | Other: Arterial Tonometry, Diagnostic Test: Echocardiogram, Diagnostic Test: Carotid Ultrasounds, Diagnostic Test: Elastography, Other: Ankle-Brachial Index, Other: Microneurography with sympathoexcitatory maneuversHealthy subjects will undergo a series of diagnostic studies to assess neurovascular function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For SCAD patients: history of SCAD as confirmed by coronary angiography or cardiac computed tomography angiography
- For controls: no cardiac disease history
Key exclusion criteria (4 listed)
- Pregnancy
- Known or suspected unstable cardiac condition within 4 weeks of the study
- Active treatment with anticoagulation or dual antiplatelet therapy
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial TonometryWe will measure arterial stiffness using arterial tonometry. | Other | Healthy Control Group, Spontaneous coronary artery dissection (SCAD) group |
| EchocardiogramWe will collect limited ultrasound images of the heart. | Diagnostic test | Healthy Control Group, Spontaneous coronary artery dissection (SCAD) group |
| Carotid UltrasoundsWe will perform ultrasound imaging of the carotid artery. | Diagnostic test | Healthy Control Group, Spontaneous coronary artery dissection (SCAD) group |
| ElastographyWe will measure the elastic properties of the arteries using elastography. | Diagnostic test | Healthy Control Group, Spontaneous coronary artery dissection (SCAD) group |
| Ankle-Brachial IndexWe will measure the ankle-brachial index to assess peripheral artery blood flow. | Other | Healthy Control Group, Spontaneous coronary artery dissection (SCAD) group |
| Microneurography with sympathoexcitatory maneuversWe 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, Spontaneous coronary artery dissection (SCAD) group |
Primary outcome
Arterial thickness
Time frame: Baseline
Measured by carotid ultrasound intimal media thickness reporting in mm
Arterial stiffness
Time frame: Baseline
Measured by carotid ultrasound pulse wave velocity reporting in m/s
Baroreflex sensitivity
Time frame: Baseline
The slope between heart rate and blood pressure at rest and during the Valsalva Maneuver (ms/mmHg)
Sympathetic response to stress
Time frame: Baseline
Blood pressure or muscle sympathetic nerve activity response to sympathoexcitatory stressors (mm/Hg or bursts/min).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marysia Tweet, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial Tonometry, Echocardiogram and Carotid Ultrasounds in people with Spontaneous Coronary Artery Dissection and Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Engrav (507-255-6938, Engrav.Pamela@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial thickness (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.