NCT02502955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

June 16, 2015

Last Update Submit

August 7, 2017

Conditions

Death

Keywords

Quality ControlCardiosurgeryCardiologyVascular SurgeryICU

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Quality evaluation (satisfaction of the clinicians evaluated by a standardized questionnaire)

    2 weeks

Interventions

Comparison autopsy methodsPROCEDURE

Comparison of post-mortem angiography/virtual autopsy and medical autopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years or older AND
  • dying after a cardiological intervention or a cardio-/vascular surgery AND
  • oral informed consent from next of kind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamburg, 20251, Germany

Location

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dominic Wichmann, MD

    Department of Intensive Care Medicine, University Medical Center Hamburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

July 20, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

DE(1)