Coronary Endothelial DysfunctionNCT00975559
The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
An observational study of Coronary Endothelial Dysfunction and Apical Ballooning Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The aim of this study is to measure how different people respond to mental stress. The investigators will measure if there are differences in cardiovascular responses to mental stress among different groups of subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Endothelial Dysfunction, Apical Ballooning Syndrome, Myocardial Infarction
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Normal volunteers 2. Apical Ballooning syndrome as proven during coronary angiogram 3. Coronary Endothelial Dysfunction as proven during coronary angiogram 4. Women who have had a Myocardial Infarction with subsequent Percutaneous Intervention
Who may be able to join
- Patients must be identified in one of the four groups outlined in "study population description."
Who cannot join
- Other co-morbidities that would make the testing not possible.
- Women who have had a mastectomy and would not have an arm that could be occluded during the reactive hyperemia portion of the Peripheral arterial tonometry testing.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to measure how different people respond to mental stress. The investigators will measure if there are differences in cardiovascular responses to mental stress among different groups of subjects. In one part of the study the investigators will compare the cardiovascular responses to mental stress between healthy women and healthy men. In another part of the study, the investigators will compare the cardiovascular responses to mental stress between women with apical ballooning syndrome and healthy post-menopausal women. The investigators hypothesize that healthy men will have an increased vascular response to and decreased endothelial function in response to to mental stress, compared to health women. Furthermore, the investigators hypothesize that women with apical ballooning syndrome will have an increased vascular response to and decreased endothelial function in response to mental stress.
- Medical subject headings
- Takotsubo Cardiomyopathy, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal volunteers | Normal study volunteers with no prior history of coronary artery disease | |
| Apical Ballooning Syndrome | Women who have had a documented Apical Ballooning event as shown by coronary angiogram | |
| Coronary Endothelial Dysfunction | Patients who have been diagnosed with Endothelial Dysfunction via a coronary angiogram with acetylcholine challenge | |
| Myocardial Infarction | Women diagnosed with a Myocardial Infarction who subsequently had a Percutaneous Intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startSep 2003
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Endothelial DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Amir Lerman, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975559
- Sponsor's protocol ID
- 1881-03
- Status last verified
- Apr 2012
- First submitted
- 9 Sep 2009
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
- ClinicalTrials.gov ID
- NCT00975559
- Acronym / sponsor ID
- 1881-03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2003
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Sep 2009 (estimated)
- 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 aim of this study is to measure how different people respond to mental stress. The investigators will measure if there are differences in cardiovascular responses to mental stress among different groups of subjects. In one part of the study the investigators will compare the cardiovascular responses to mental stress between healthy women and healthy men. In another part of the study, the investigators will compare the cardiovascular responses to mental stress between women with apical ballooning syndrome and healthy post-menopausal women. The investigators hypothesize that healthy men will have an increased vascular response to and decreased endothelial function in response to to mental stress, compared to health women. Furthermore, the investigators hypothesize that women with apical ballooning syndrome will have an increased vascular response to and decreased endothelial function in response to mental stress.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal volunteers | – | –Normal study volunteers with no prior history of coronary artery disease |
| Apical Ballooning Syndrome | – | –Women who have had a documented Apical Ballooning event as shown by coronary angiogram |
| Coronary Endothelial Dysfunction | – | –Patients who have been diagnosed with Endothelial Dysfunction via a coronary angiogram with acetylcholine challenge |
| Myocardial Infarction | – | –Women diagnosed with a Myocardial Infarction who subsequently had a Percutaneous Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Normal volunteers 2. Apical Ballooning syndrome as proven during coronary angiogram 3. Coronary Endothelial Dysfunction as proven during coronary angiogram 4. Women who have had a Myocardial Infarction with subsequent Percutaneous Intervention
Key inclusion criteria (1 listed)
- Patients must be identified in one of the four groups outlined in "study population description."
Key exclusion criteria (2 listed)
- Other co-morbidities that would make the testing not possible.
- Women who have had a mastectomy and would not have an arm that could be occluded during the reactive hyperemia portion of the Peripheral arterial tonometry testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Endothelial Dysfunction and Apical Ballooning Syndrome, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 26 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 26 Apr 2012.