NCT00443989

Brief Summary

We will conduct a prospective cohort study evaluating the incidence of and optimal risk estimation model for major perioperative cardiovascular events in consecutive patients undergoing noncardiac surgery at the 'Herlev University Hospital'. This national pilot study in Denmark together with other national studies will inform the feasibility of a large prospective international cohort study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

March 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 30, 2008

Status Verified

March 1, 2007

Enrollment Period

10 months

First QC Date

March 6, 2007

Last Update Submit

May 27, 2008

Conditions

Myocardial InfarctionCardiac Arrest

Keywords

Perioperative Myocardial InfarctionStrokeCardiac DeathCardiac ArrestTroponin-TNon-Cardiac surgeryDeath

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients for major surgery more than 45 years of age

You may qualify if:

  • All patients undergoing noncardiac surgery are eligible if they:
  • Are \> 45 years of age
  • Are undergoing noncardiac surgery requiring overnight hospital admission; AND
  • Will receive a general or regional anesthetic

You may not qualify if:

  • We will exclude patients who refuse 30 day or 6 month follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herlev Hospital

Herlev, Copenhagen, 2650, Denmark

Location

Department of Anesthesiology and Intensive Care, Herlev University Hospital

Herlev, Copenhagen, DK-2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Troponin-T

MeSH Terms

Conditions

Myocardial InfarctionHeart ArrestStrokeDeath

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Søren Borchorst, M.D.

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 7, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

May 30, 2008

Record last verified: 2007-03

Locations

DK(2)