Takotsubo CardiomyopathyNCT02361073
The Role of Emotional Stress in Patients With Stress-induced Cardiomyopathy
An observational study of Takotsubo Cardiomyopathy, run by University of Magdeburg at 1 site in Germany.
Trial summary
The event-related potentials may be different in patients with Takotsubo cardiomyopathy than in patients without Takotsubo. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Takotsubo Cardiomyopathy
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Aug 2015
- How long will I take part?
- 6 Months
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Takotsubo Cardiomyopathy compared with healthy subjects and patients with ACS.
Who may be able to join
- Age >18 years
- Written informed consent
- Takotsubo cardiomyopathy for group 1. ACS for group 3.
Who cannot join
- Psychiatric diseases
- Impaired versus, non compliant patients, heart disease for group 2.
- Takotsubo-like syndrome.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Magdeburg
Magdeburg, 39112
Samir M Said, MD
Katja Mueller
About this study
Official title: Event-related Potentials in Patients With Takotsubo Cardiomyopathy
The event-related potentials may be different in patients with Takotsubo cardiomyopathy than in patients without Takotsubo.
Read the detailed description
In patients with Takotsubo diagnosed by coronary angiography, the event-related potentials are investigated and compared with a control group, which consists of subjects without Takotsubo.
- Conditions
- Takotsubo Cardiomyopathy
- Keywords
- Stress-induced cardiomyopathy, ERP
- Medical subject headings
- Takotsubo Cardiomyopathy
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 |
|---|---|---|
| Takotsubo | Not described | |
| Healthy | Not described | |
| ACS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-related potentials
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJun 2011
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Samir Said, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361073
- Sponsor's protocol ID
- UM-PC-0813
- Status last verified
- Feb 2015
- First submitted
- 9 Jan 2013
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Event-related Potentials in Patients With Takotsubo Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02361073
- Acronym / sponsor ID
- UM-PC-0813
- Conditions
- Takotsubo Cardiomyopathy
- Keywords
- Stress-induced cardiomyopathy, ERP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 11 Feb 2015 (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 event-related potentials may be different in patients with Takotsubo cardiomyopathy than in patients without Takotsubo.
Detailed description
In patients with Takotsubo diagnosed by coronary angiography, the event-related potentials are investigated and compared with a control group, which consists of subjects without Takotsubo.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Takotsubo | – | – |
| Healthy | – | – |
| ACS | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Takotsubo Cardiomyopathy compared with healthy subjects and patients with ACS.
Key inclusion criteria (3 listed)
- Age >18 years
- Written informed consent
- Takotsubo cardiomyopathy for group 1. ACS for group 3.
Key exclusion criteria (3 listed)
- Psychiatric diseases
- Impaired versus, non compliant patients, heart disease for group 2.
- Takotsubo-like syndrome.
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
Event-related potentials
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
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 Takotsubo Cardiomyopathy, run by University of Magdeburg at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 11 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samir M Said, MD (+49-3916715206, samir.said@med.ovgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-related potentials (time frame: up to 1 year). 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 11 Feb 2015.