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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:
Information provided by (Responsible Party):
Douglas Morris, Emory University
ClinicalTrials.gov Identifier:
NCT00209144
First received: September 14, 2005
Last updated: June 13, 2014
Last verified: June 2014
  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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Douglas Morris, Professor, Emory University
ClinicalTrials.gov 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:
Inflammation
Thrombosis
Hyperglycemia
Myocardial Infarction
Angioplasty

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

ClinicalTrials.gov processed this record on November 24, 2014