NCT00589459

Brief Summary

The primary goal of this study is to measure the prevalence of undiagnosed pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (ACS) compared to men. Inpatients with confirmed ACS (and no known prior history of diabetes) are invited to return to the Yale Hospital Research Unit 6-8 weeks after hospital discharge for an oral glucose tolerance test to identify individuals with pre-diabetes and diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2001

Longer than P75 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

October 1, 2001

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

December 27, 2007

Last Update Submit

August 29, 2023

Conditions

Pre-diabetesDiabetes

Keywords

undiagnosed diabetesundiagnosed pre-diabetesacute coronary syndromeundiagnosed pre-diabetes and undiagnosed diabetes

Outcome Measures

Primary Outcomes (1)

  • Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes

    after hospitalization for acute coronary syndrome

Study Arms (2)

1

non-diabetic women with acute coronary syndrome (ACS)

2

non-diabetic men with acute coronary syndrome (ACS)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women and men admitted with an acute coronary syndrome who do not have a prior diagnosis of diabetes

You may qualify if:

  • acute coronary syndrome
  • age \> 30 yrs

You may not qualify if:

  • previously diagnosed diabetes
  • ACS due to substance abuse or trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Yale Center for Clinical Investigation

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes MellitusAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Barbara I Gulanski, MD, MPH

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 27, 2007

First Posted

January 9, 2008

Study Start

October 1, 2001

Primary Completion

September 1, 2005

Study Completion

December 1, 2008

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(2)