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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00209144
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 16, 2014
Information provided by (Responsible Party):
Douglas Morris, Emory University

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Intensive insulin therapy Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2004
Primary Completion Date : December 2005
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Angioplasty with Insulin
Coming in with acute infarct and received angioplasty with intensive insulin therapy
Drug: Intensive insulin therapy
No Intervention: Angioplasty w/o Insulin
Coming in with acute infarct and received angioplasty

Primary Outcome Measures :
  1. Troponin levels [ Time Frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure) ]

Secondary Outcome Measures :
  1. CRP level [ Time Frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure) ]
  2. B-type natriuretic peptide levels. [ Time Frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209144

United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Principal Investigator: Douglas C Morris, MD Emory Heart Center

Responsible Party: Douglas Morris, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209144     History of Changes
Other Study ID Numbers: 867-2004
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014

Keywords provided by Douglas Morris, Emory University:
Myocardial Infarction

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs