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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209144
First Posted: September 21, 2005
Last Update Posted: June 16, 2014
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.
Information provided by (Responsible Party):
Douglas Morris, Emory University
  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: Intensive insulin therapy Phase 1

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Douglas Morris, Emory University:

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

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

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

  Eligibility

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
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
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


Locations
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
Investigators
Principal Investigator: Douglas C Morris, MD Emory Heart Center
  More Information

Responsible Party: Douglas Morris, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209144     History of Changes
Other Study ID Numbers: 867-2004
6-56553
First Submitted: September 14, 2005
First Posted: September 21, 2005
Last Update Posted: June 16, 2014
Last Verified: June 2014

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

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