Apical Ballooning SyndromeNCT01885975
Personality Profile of Patients With Apical Ballooning Syndrome
An observational study of Apical Ballooning Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will manifest a personality profile that differs than that of a population of similar range of ethnic and socioeconomic status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Ballooning Syndrome
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted among participants in the Mayo Clinic Apical Ballooning Registry. These patients were prospectively diagnosed with Apical Ballooning Syndrome at the time of presentation with their acute illness, and consented to participation in a registry. They are residents of Olmsted County, and the surrounding regions for which the Mayo Clinic serves as a tertiary care center. Enrollment in the registry requires satisfaction of standard criteria for the diagnosis of ABS and includes the administration of a standardized questionnaire. Subjects have agreed to participate in yearly follow up questionnaires about their health status.
Who may be able to join
- Patients who have suffered with ABS
- Adults (18 years or older)
- Able to read English at a 6th grade level (questionnaires are self-administered and written in English)
Who cannot join
- Have withdrawn from the registry
- Have died
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Personality Profile of Patients With Apical Ballooning Syndrome (ABS)
The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will manifest a personality profile that differs than that of a population of similar range of ethnic and socioeconomic status.
- Conditions
- Apical Ballooning Syndrome
- Keywords
- Apical Ballooning syndrome, Personality
- Medical subject headings
- Takotsubo Cardiomyopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of personality traits as assessed by the "NEO-PI-3"
The "NEO PI-3" measures the five major domains of personality, which are:
- Neuroticism
- Extraversion
- Openness
- Agreeableness
- Conscientiousness
Measured: Baseline: the traits will be assessed once upon enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical Ballooning SyndromeStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhiram Prasad, Mayo Clinic
- Investigators
- Abhiram Prasad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885975
- Sponsor's protocol ID
- 13-003419
- Status last verified
- Feb 2015
- First submitted
- 20 Jun 2013
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality Profile of Patients With Apical Ballooning Syndrome (ABS)
- ClinicalTrials.gov ID
- NCT01885975
- Acronym / sponsor ID
- 13-003419
- Conditions
- Apical Ballooning Syndrome
- Keywords
- Apical Ballooning syndrome, Personality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jun 2013 (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 investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will manifest a personality profile that differs than that of a population of similar range of ethnic and socioeconomic status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted among participants in the Mayo Clinic Apical Ballooning Registry. These patients were prospectively diagnosed with Apical Ballooning Syndrome at the time of presentation with their acute illness, and consented to participation in a registry. They are residents of Olmsted County, and the surrounding regions for which the Mayo Clinic serves as a tertiary care center. Enrollment in the registry requires satisfaction of standard criteria for the diagnosis of ABS and includes the administration of a standardized questionnaire. Subjects have agreed to participate in yearly follow up questionnaires about their health status.
Key inclusion criteria (3 listed)
- Patients who have suffered with ABS
- Adults (18 years or older)
- Able to read English at a 6th grade level (questionnaires are self-administered and written in English)
Key exclusion criteria (2 listed)
- Have withdrawn from the registry
- Have died
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
Range of personality traits as assessed by the "NEO-PI-3"
Time frame: Baseline: the traits will be assessed once upon enrollment into the study
The "NEO PI-3" measures the five major domains of personality, which are: * Neuroticism * Extraversion * Openness * Agreeableness * Conscientiousness
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 16 Feb 2015.
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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.
Abhiram Prasad, MD 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?
An observational study of 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 3 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 16 Feb 2015. 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.
What does the primary outcome measure?
Range of personality traits as assessed by the "NEO-PI-3" (time frame: Baseline: the traits will be assessed once upon enrollment into the study). 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 16 Feb 2015.