Phase 1 Study of Potential Anti-Inflammatory Effects of Glucose Control During Acute Myocardial Infarction.

This study is currently recruiting participants.

Verified by Emory University, September 2005

First Received: September 14, 2005 No Changes Posted

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00209144

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Drug: Intense glycemic control using intravenous insulin infusion	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Intense Glycemic Control on Markers of Inflammation and Thrombosis in Patients Treated With Percutaneous Coronary Intervention for Acute Myocardial Infarction.

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Levels of molecular markers of inflammation and thrombosis.

Secondary Outcome Measures:

Cardiac enzyme and B-type natriuretic peptide levels.

Estimated Enrollment:	58
Study Start Date:	October 2004
Estimated Study Completion Date:	October 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: Patients to be treated with percutaneous coronary intervention for myocardial infarction.

Exclusion Criteria: MI > 6 hrs duration Thrombolytic therapy (within last 2 days) Recent inflammatory/infectious illness (last 2 weeks) Pregnancy Renal insufficiency (Cr > 2.0) Type I Diabetes Mellitus Initial BG >110 but <140 Enrollment in another research study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209144

Contacts

Contact: Spencer J Palmer, MD

404-686-1000

spalm03@emory.edu

Locations

United States, Georgia
Emory Crawford Long Hospital	Recruiting
Atlanta, Georgia, United States, 30329
Contact: Spencer J Palmer, MD 404-686-1000 spalm03@emory.edu
Contact: Douglas C Morris, MD 404-778-2253 douglas_morris@emoryhealthcare.org
Principal Investigator: Douglas C Morris, MD
Emory University Hospital	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Spencer J Palmer, MD 404-686-1000 spalm03@emory.edu
Contact: Douglas C Morris, MD 404-778-2253 douglas_morris@emoryhealthcare.org
Principal Investigator: Douglas C Morris, MD

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Douglas C Morris, MD

Emory Heart Center

More Information

No publications provided

Study ID Numbers:	867-2004, 6-56553
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00209144 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Inflammation
Thrombosis
Hyperglycemia
Myocardial Infarction
Angioplasty

Study placed in the following topic categories:

Necrosis
Heart Diseases
Hyperglycemia
Myocardial Ischemia
Vascular Diseases
Ischemia

Infarction
Myocardial Infarction
Insulin
Thrombosis
Inflammation

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on August 30, 2009