NCT00209144

Brief Summary

The purpose of this study is to determine if intense control of high glucose levels in patients treated with angioplasty for heart attack has anti-inflammatory and anti-thrombotic effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2004

Typical duration for phase_1

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, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

September 14, 2005

Last Update Submit

June 13, 2014

Conditions

Acute Myocardial Infarction

Keywords

InflammationThrombosisHyperglycemiaMyocardial InfarctionAngioplasty

Outcome Measures

Primary Outcomes (1)

  • Troponin levels

    Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)

Secondary Outcomes (2)

  • CRP level

    Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)

  • B-type natriuretic peptide levels.

    Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)

Study Arms (2)

Angioplasty with Insulin

EXPERIMENTAL

Coming in with acute infarct and received angioplasty with intensive insulin therapy

Drug: Intensive insulin therapy

Angioplasty w/o Insulin

NO INTERVENTION

Coming in with acute infarct and received angioplasty

Interventions

Intensive insulin therapyDRUG
Angioplasty with Insulin

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

InflammationThrombosisHyperglycemiaMyocardial Infarction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaNecrosis

Study Officials

  • Douglas C Morris, MD

    Emory Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2006

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

US(2)