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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00209144
First received: September 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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

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

Keywords provided by Emory University:
Inflammation
Thrombosis
Hyperglycemia
Myocardial Infarction
Angioplasty

Additional relevant MeSH terms:
Infarction
Inflammation
Myocardial Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013