Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery | NCT02502955

Studies
Virtual Autopsy in Cardiology, Cardio- and Vascular-Surgery

NCT02502955

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

Aug 8, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Death

Interventions

Comparison autopsy methods

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Jul 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Jun 16, 2015

First Submission Date that Met QC Criteria

Jul 17, 2015

First Posted Date

Jul 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2017

Last Update Posted Date

Aug 8, 2017Actual

Name	Class
University Hospital, Basel, Switzerland	OTHER
Insel Gruppe AG, University Hospital Bern	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparison autopsy methods	Procedure	Comparison of post-mortem angiography/virtual autopsy and medical autopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominic Wichmann, MD	Department of Intensive Care Medicine, University Medical Center Hamburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)		Hamburg		20251	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided