- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01151176
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed study is a one center open-label randomized controlled clinical trial.Coronary Intensive Care of one hospital in the city of Curitiba, PR, Brazil will be assessed.
Consenting eligible subjects will be randomized to either the intensive insulin infusion therapy group (ITG) or the conventional therapy group (CTG).
This particular insulin infusion was adapted of a protocol has been used before in patients who underwent to cardiothoracic surgery and its efficacy has been reported in the literature.
The control group will be selected following the same set of inclusion and exclusion criteria. Patients will be randomized to receive SC regular insulin 4 times daily (before meals and bedtime) or every 6 hours if they are NPO .
Data will be collected for history of diabetes, heart disease ; hypertension; hyperlipidemia; Current smoker; Cardiac treatment (Aspirin, Beta Blockers, ACE inhibitor/A2RB, Nitrates, Statin, Fibrate) Diabetes treatment(Insulin, Metformin, Sulphonylureas) Data will be collect for Baseline BGL , A1C level, Troponin, CPK, CKP-Mb, K, Creatinine. Classify Infarct type : Anterior/anteroseptal, Inferior, Non-ST-segment elevation myocardial infarction, Not classified Cardiac intervention : PTCA , Thrombolysis,No reperfusion, Heparin or low-molecular weight heparin.
Subjects allocated to ITG will be placed on Grady Health System protocol, and those in CTG will follow the sliding scale nomograms. Insulin replacement will start during first 24h of admission. Patients will be followed during all hospital stay, but only at ICU the CIII and SC insulin replacement will be compared. After ICU discharge they will follow they will be followed by their physician with recommendations to keep blod glucose<180mg/dL.
Patients will be followed up to 90 days after hospital discharge with phone call.Subjects will be contacted to obtain information regarding the occurrence of cardiovascular events following discharge. If the subject is not contactable, the next of kin and/or the subject's general practitioner would be contacted. Where no information could be obtained, a request will be made to the Department of Births and Deaths.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
PR
-
Curitiba, PR, Brazil, 80420-011
- Hospital Cruz Vermelha Brasileira-Filial do Estado do Paraná
-
-
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Emory University School Of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under 18 years of age
- Pregnant or lactating female
- Diabetes ketoacidosis
- Heart failure
- Cardiogenic shock
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Insulin
Intensive Insulin Therapy
|
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
Other Names:
Regular Insulin SC according to Blood Glucose(mg/dL) and Insulin Sensitive with usual dose describe and less 2U for sensitive and plus 2U for insulin resistant: Blood Glucose >141-180=4U ;181-220=6U; 221-260=8U; 261-300=10U;301-350=12U; 351-400=14U; > 400=16U
Other Names:
|
Other: Regular Insulin
Sub Cutaneous Regular Insulin
|
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
Other Names:
Regular Insulin SC according to Blood Glucose(mg/dL) and Insulin Sensitive with usual dose describe and less 2U for sensitive and plus 2U for insulin resistant: Blood Glucose >141-180=4U ;181-220=6U; 221-260=8U; 261-300=10U;301-350=12U; 351-400=14U; > 400=16U
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences in daily blood glucose mean concentration between treatment groups
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC)
Time Frame: 18 month
|
18 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Silmara AO Leite, PhD, MD, Universidade Positivo
- Study Chair: Guilhermo E Umpierrez, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCV-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Coronary Syndrome
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
Meditrix CorpNational University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health UniversityRecruitingChronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeJapan, Ireland
-
OrbusNeichDuke Clinical Research Institute; OrbusNeich Medical K.K.CompletedCoronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary SyndromeUnited States, Japan
-
Medical University of WarsawRecruitingAcute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromePoland
-
Niguarda HospitalCompletedAcute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic AneurysmsItaly
-
Sohag UniversityRecruitingLeft Main Coronary Artery Disease With Acute Coronary SyndromeEgypt
-
Eli Lilly and CompanyDaiichi Sankyo, Inc.CompletedCoronary Arteriosclerosis | Acute Coronary SyndromesUnited States
-
University of PatrasCompletedCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)Greece
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Yonsei UniversityCompletedAcute Coronary Syndrome (ACS)Korea, Republic of
Clinical Trials on Regular Insulin
-
Emory UniversityAmerican Diabetes AssociationCompletedDiabetesUnited States
-
Xeris PharmaceuticalsCompletedDiabetes Mellitus, Type 1 | Insulin-dependent Diabetes MellitusUnited States
-
King Edward Medical UniversityCompletedTo Assess the Glycemic Control of Insulin Glargine in Combination With Regular Insulin in Type 1 Diabetes in ChildrenPakistan
-
HealthPartners InstituteRecruiting
-
Cairo UniversitySanofiUnknownLiver Cirrhosis | Type 2 DiabetesEgypt
-
Eli Lilly and CompanyInsulet CorporationCompletedType 2 Diabetes MellitusUnited States, Puerto Rico
-
King Faisal Specialist Hospital & Research CenterCompletedDiabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral NutritionSaudi Arabia
-
The University of Texas Health Science Center,...Completed
-
Sohag UniversityCompletedType 1 Diabetes MellitusEgypt
-
University of PittsburghSanofiCompletedHyperglycemia | Type 2 DiabetesUnited States