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

This study has been completed.
Information provided by (Responsible Party):
Douglas Morris, Emory University Identifier:
First received: September 14, 2005
Last updated: June 13, 2014
Last verified: June 2014

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: Intensive insulin therapy
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:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Troponin levels [ Time Frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CRP level [ Time Frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure) ] [ Designated as safety issue: No ]
  • B-type natriuretic peptide levels. [ Time Frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure) ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: October 2004
Study Completion Date: December 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00209144

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

No publications provided

Responsible Party: Douglas Morris, Professor, Emory University Identifier: NCT00209144     History of Changes
Other Study ID Numbers: 867-2004, 6-56553
Study First Received: September 14, 2005
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Myocardial Infarction

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 02, 2015