Study Stopped
Administrative problems makes changes in hospital staff New clinical research team will restart
Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
1 other identifier
interventional
130
2 countries
2
Brief Summary
The study aims to demonstrate that a simple intravenous insulin algorithm can be implemented in Latin America and will result in safe and better glucose control in patients with Acute Coronary Syndrome (ACS) compared with SC insulin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2012
2 active sites
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
First Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 28, 2010
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 19, 2012
June 1, 2012
1 year
March 4, 2010
June 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in daily blood glucose mean concentration between treatment groups
18 months
Secondary Outcomes (1)
Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC)
18 month
Study Arms (2)
Insulin
ACTIVE COMPARATORIntensive Insulin Therapy
Regular Insulin
OTHERSub Cutaneous Regular Insulin
Interventions
1,8U Regular insulin/h from 180mg/dL of blood glucose increasing each hour according to capillary blood glucose. Between 100-150mg/dL keep infusion and bellow 100mg/dL stop infusion
Eligibility Criteria
You may qualify if:
- Male or female
- Age 18 or older
- Evidence of AMI within the last 24 h (troponin-T \>0.1mcg/l) or electrographic criteria of ST-segment elevation in two limb leads)
- Evidence of Unstable Angina
- Blood glucose \>180mg/dL at admission with or without preexisting diabetes
- Willing to give informed consent
- Access to telephone communications after hospital discharge
You may not qualify if:
- Under 18 years of age
- Pregnant or lactating female
- Diabetes ketoacidosis
- Heart failure
- Cardiogenic shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Positivolead
- Emory Universitycollaborator
Study Sites (2)
Emory University School of Medicine
Atlanta, Georgia, 30303, United States
Hospital Cruz Vermelha Brasileira-Filial do Estado do Paraná
Curitiba, Paraná, 80420-011, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silmara AO Leite, PhD, MD
Universidade Positivo
- STUDY CHAIR
Guilhermo E Umpierrez, MD
Emory University
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
- PhD
Study Record Dates
First Submitted
March 4, 2010
First Posted
June 28, 2010
Study Start
August 1, 2012
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
June 19, 2012
Record last verified: 2012-06