Cardiac DiseaseNCT05191173
Perioperative Three-dimensional Echocardiography in Cardioanesthesia.
An observational study of Cardiac Disease and Vascular Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The aim of this study is to investigate the significance of intraoperative echocardiography on the surgical course and association with patient outcome. Of particular interest is the three-dimensional assessment of cardiac and valvular function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Vascular Diseases
- What is being tested?
- Cardiac Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to Dec 2025
- How long will I take part?
- 2 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mixed population of adult patients undergoing cardiac surgery.
Who may be able to join
- Cardiac surgery or surgery on the vessels near the heart
Who cannot join
- Pregnant patients
- Unfeasibility of intraoperative echocardiography in contraindications to transesophageal echocardiography: esophageal carcinoma, varices, diverticula, strictures, acute esophagitis, previous esophageal or gastric bleeding, symptomatic hiatal hernia.
- No written consent obtainable.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Tübingen
Tübingen
Harry Magunia, MD, PhD
About this study
The aim of this study is to investigate the significance of intraoperative echocardiography on the surgical course and association with patient outcome. Of particular interest is the three-dimensional assessment of cardiac and valvular function. The patient course from surgery to the time of hospital discharge will be followed up.
- Conditions
- Cardiac Disease, Vascular Diseases
- Being tested
- Cardiac Surgery
- Medical subject headings
- Heart Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
No intervention, just observation is performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
In Hospital Mortality
Measured: up to 90 days
1-year Mortality
Measured: 1 year
Secondary outcomes (3)
ICU Length of Stay
Measured: up to 90 days
Days on Mechanical Ventilation
Measured: up to 90 days
Days with Circulatory Support
Measured: up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jun 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191173
- Sponsor's protocol ID
- EchoRegistryCardiac
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 13 Jan 2022
- 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 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Three-dimensional Echocardiography in Cardioanesthesia.
- ClinicalTrials.gov ID
- NCT05191173
- Acronym / sponsor ID
- EchoRegistryCardiac
- Conditions
- Cardiac Disease, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jan 2022 (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 aim of this study is to investigate the significance of intraoperative echocardiography on the surgical course and association with patient outcome. Of particular interest is the three-dimensional assessment of cardiac and valvular function. The patient course from surgery to the time of hospital discharge will be followed up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mixed population of adult patients undergoing cardiac surgery.
Key inclusion criteria (1 listed)
- Cardiac surgery or surgery on the vessels near the heart
Key exclusion criteria (3 listed)
- Pregnant patients
- Unfeasibility of intraoperative echocardiography in contraindications to transesophageal echocardiography: esophageal carcinoma, varices, diverticula, strictures, acute esophagitis, previous esophageal or gastric bleeding, symptomatic hiatal hernia.
- No written consent obtainable.
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 |
|---|---|---|
| Cardiac SurgeryNo intervention, just observation is performed. | Procedure or surgery | – |
Primary outcome
In Hospital Mortality
Time frame: up to 90 days
1-year Mortality
Time frame: 1 year
3 secondary outcomes
ICU Length of Stay
Time frame: up to 90 days
Days on Mechanical Ventilation
Time frame: up to 90 days
Days with Circulatory Support
Time frame: up to 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- 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. 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 Cardiac Disease and Vascular Diseases, run by University Hospital Tuebingen 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 1 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 13 Jan 2022. 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 Harry Magunia, MD, PhD (+4970712986564, harry.magunia@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Hospital Mortality (time frame: up to 90 days). The study lists 2 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 13 Jan 2022.