Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery

August 7, 2017 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Completed

Conditions

Death

Intervention / Treatment

Procedure: Comparison autopsy methods

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Hamburg, Germany, 20251
    - Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients dying after a cardiological intervention or a cardio-/vascular surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality evaluation (satisfaction of the clinicians evaluated by a standardized questionnaire) Time Frame: 2 weeks	Diagnoses made by any autopsy method will be compared to ante mortem diagnoses.	2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

University Hospital Inselspital, Berne

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Dominic Wichmann, MD, Department of Intensive Care Medicine, University Medical Center Hamburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified