DeathNCT02502955
Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery
An observational study of Death, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Today complex vascular and cardiological interventions are performed in severely ill patients. Autopsy is the reference standard for quality control for almost two centuries, but autopsy rates for patients dying in hospitals are decreasing rapidly. Virtual autopsy has shown to be a good alternative for classic autopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death
- What is being tested?
- Comparison autopsy methods
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Aug 2017
- 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: Patients dying after a cardiological intervention or a cardio-/vascular surgery.
Who may be able to join
- 18 years or older AND
- dying after a cardiological intervention or a cardio-/vascular surgery AND
- oral informed consent from next of kind
Who cannot join
- not fulfilling all inclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, 20251
About this study
Today complex vascular and cardiological interventions are performed in severely ill patients.
Autopsy is the reference standard for quality control for almost two centuries, but autopsy rates for patients dying in hospitals are decreasing rapidly.
Virtual autopsy has shown to be a good alternative for classic autopsy.
Read the detailed description
Patients dying within 96h after a cardiological intervention of a cardio-/vascular-surgery are eligible to be included in the study.
If the next of kin give oral informed consent a virtual autopsy based on a CT angiography followed by a classic medical autopsy will be performed.
Ante mortem findings will be compared to findings from both autopsy methods and presented to the clinicians.
Primary outcome will be the inter-method agreement. Secondary outcome will be the satisfaction of the clinicians evaluated by a standardized questionnaire.
- Conditions
- Death
- Being tested
- Comparison autopsy methods
- Keywords
- Quality Control, Cardiosurgery, Cardiology, Vascular Surgery, ICU
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison autopsy methodsProcedure or surgery
Comparison of post-mortem angiography/virtual autopsy and medical autopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of virtual autopsy and medical autopsy (inter-method agreement)
Diagnoses made by virtual autopsy will be compared to diagnoses made by classic autopsy.
Measured: 1 week
Secondary outcomes (1)
Quality evaluation (satisfaction of the clinicians evaluated by a standardized questionnaire)
Diagnoses made by any autopsy method will be compared to ante mortem diagnoses.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic Wichmann, MD, Principal investigator, Department of Intensive Care Medicine, University Medical Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502955
- Sponsor's protocol ID
- VA-4 Cardio
- Status last verified
- Aug 2017
- First submitted
- 16 Jun 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery
- ClinicalTrials.gov ID
- NCT02502955
- Acronym / sponsor ID
- VA-4 Cardio
- Conditions
- Death
- Keywords
- Quality Control, Cardiosurgery, Cardiology, Vascular Surgery, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Insel Gruppe AG, University Hospital Bern
- Study start
- May 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Jul 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.
Today complex vascular and cardiological interventions are performed in severely ill patients.
Autopsy is the reference standard for quality control for almost two centuries, but autopsy rates for patients dying in hospitals are decreasing rapidly.
Virtual autopsy has shown to be a good alternative for classic autopsy.
Detailed description
Patients dying within 96h after a cardiological intervention of a cardio-/vascular-surgery are eligible to be included in the study.
If the next of kin give oral informed consent a virtual autopsy based on a CT angiography followed by a classic medical autopsy will be performed.
Ante mortem findings will be compared to findings from both autopsy methods and presented to the clinicians.
Primary outcome will be the inter-method agreement. Secondary outcome will be the satisfaction of the clinicians evaluated by a standardized questionnaire.
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
- Patients dying after a cardiological intervention or a cardio-/vascular surgery.
Key inclusion criteria (3 listed)
- 18 years or older AND
- dying after a cardiological intervention or a cardio-/vascular surgery AND
- oral informed consent from next of kind
Key exclusion criteria (1 listed)
- not fulfilling all inclusion criteria
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 |
|---|---|---|
| Comparison autopsy methodsComparison of post-mortem angiography/virtual autopsy and medical autopsy | Procedure or surgery | – |
Primary outcome
Agreement of virtual autopsy and medical autopsy (inter-method agreement)
Time frame: 1 week
Diagnoses made by virtual autopsy will be compared to diagnoses made by classic autopsy.
1 secondary outcome
Quality evaluation (satisfaction of the clinicians evaluated by a standardized questionnaire)
Time frame: 2 weeks
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 8 Aug 2017.
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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.
Dominic Wichmann, MD principal investigator
Department of Intensive Care Medicine, University Medical Center Hamburg
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 Death, run by Universitätsklinikum Hamburg-Eppendorf 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 1 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 8 Aug 2017. 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?
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?
Agreement of virtual autopsy and medical autopsy (inter-method agreement) (time frame: 1 week). 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 8 Aug 2017.