NCT00362778

Brief Summary

Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. The aim of our study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Jan 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

11 months

First QC Date

August 8, 2006

Last Update Submit

March 19, 2012

Conditions

DiabetesHyperglycemiaAcute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    first 48 hours

Secondary Outcomes (1)

  • High-sensitivity C-reactive protein levels

    At 48 hours and aat hospital discharge

Study Arms (1)

Serum saline

SHAM COMPARATOR
Drug: Insulin

Interventions

InsulinDRUG

intravenous continuous insulin infusion for 48 hours

Serum saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of AMI, either with or without ST segment elevation
  • Presence of high blood glucose at admission with no previously known diabetes mellitus (DM)

You may not qualify if:

  • Age under 18 years old
  • History of DM
  • Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease)
  • Unstable AMI patients (haemodynamic instability or arrhythmic disorders)
  • Platelet aggregation or coagulation disorders
  • Severe conditions with an estimated short (under 1 year) life expectancy
  • Participation in other trials
  • Patient refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusHyperglycemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Xavier Bosch

    Cardiology Department. Hospital Clínic i Universitari Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 10, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2006

Study Completion

June 1, 2007

Last Updated

March 20, 2012

Record last verified: 2012-03