NCT00286572

Brief Summary

Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. But there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 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

January 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

5.6 years

First QC Date

February 2, 2006

Last Update Submit

March 9, 2015

Conditions

Diabetes MellitusCoronary Heart DiseaseMajor Non-cardiac Surgery

Keywords

insulin-dependent diabetes mellitusnon-insulin-dependent diabetes mellituscoronary artery diseaselong-term mortality

Outcome Measures

Primary Outcomes (1)

  • Death and/or major adverse cardiac events

    12 months after surgery

Eligibility Criteria

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

Patients with treated diabetes mellitus undergoing surgery with major risk or patients with treated diabetes mellitus and known coronary artery disease undergoing surgery with major or intermediate risk

You may qualify if:

  • diabetes mellitus with insulin or oral antidiabetics
  • proven coronary artery disease or very high risk for it
  • major non-vascular surgery

You may not qualify if:

  • emergency
  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Basel, CH, 4000, Switzerland

Location

MeSH Terms

Conditions

Diabetes MellitusCoronary DiseaseDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Coronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAutoimmune DiseasesImmune System DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Miodrag Filipovic, PD Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Daniel Bolliger

Study Record Dates

First Submitted

February 2, 2006

First Posted

February 3, 2006

Study Start

January 1, 2004

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

CH(1)