Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery

Death Clinical Trial

Official title:

Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502955
• Other study ID #: VA-4 Cardio
• Status: Completed
• Phase: N/A
• First received: June 16, 2015
• Last updated: August 7, 2017
• Start date: May 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older AND

• dying after a cardiological intervention or a cardio-/vascular surgery AND

• oral informed consent from next of kind

Exclusion Criteria:

• not fulfilling all inclusion criteria

Related Conditions & MeSH terms

• Death

Intervention

Procedure:
• Comparison autopsy methods
Comparison of post-mortem angiography/virtual autopsy and medical autopsy

Locations

Country	Name	City	State
Germany	Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	University Hospital Inselspital, Berne, University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement of virtual autopsy and medical autopsy (inter-method agreement)	Diagnoses made by virtual autopsy will be compared to diagnoses made by classic autopsy.	1 week
Secondary	Quality evaluation (satisfaction of the clinicians evaluated by a standardized questionnaire)	Diagnoses made by any autopsy method will be compared to ante mortem diagnoses.	2 weeks