Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raffaele Marfella, Second University of Naples
ClinicalTrials.gov Identifier:
NCT01016509
First received: November 18, 2009
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

A multicentric study will evaluate whether peri-procedural tight glycemic control during angioplasty revascularization for acute coronary syndrome (ACS) reduces circulating inflammatory cytokines and thrombus formation in hyperglycaemic patients. Moreover, the investigators will assess whether the tight glycemic control during the first month from coronary event reduces the incidence of coronary stent restenosis at 6-months from PCI.


Condition Intervention
Restenosis
Tight Glycemic Control
Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tight Glycemic Control During Angioplasty Revascularization for Acute Coronary Syndrome Reduces Circulating Inflammatory Cytokines and Coronary Stent Restenosis

Resource links provided by NLM:


Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • Coronary angiograms [ Time Frame: at baseline, immediately after PCI, and at 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • IVUS Imaging [ Time Frame: at baseline, immediately after PCI, and at 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
No hyperglycemia patient group
Active Comparator: Insulin 1
Conventional insulin treatment
Drug: Insulin
Continuous insulin infusion of 50 IU Actrapid HM (Novo Nordisk) in 50 ml NaCl (0.9% using a Perfusor-FM pump) will be started only when blood glucose levels exceeded 200 mg/dl and adjusted to keep blood glucose between 180 and 200 mg/dl. When blood glucose fell <180 mg/dl, insulin infusion will be tapered and eventually stopped.The infusion will be lasted until stable glycemic goal (180-200 mg/dl) at least for 24 h. After glycemic goal will be maintained for 24 h, a parenteral nutrition was stopped and feeding will be started according to European guidelines. Subcutaneous insulin will be initiated at the cessation of the infusion. After discharge from the hospital, insulin will be given as short-acting insulin before meals and long-acting insulin in the evening for 30 days from PCI in both group. The treatment goal will be fasting blood glucose and postprandial levels of <200 mg/dl.
Experimental: Insulin
Intensive insulin treatment
Drug: Insulin
Insulin infusion will be started when blood glucose levels exceeded 140 mg/dl and adjusted to maintain glycemia at 80-140 mg/dl. During insulin infusion, oral feeding will be stopped and parenteral nutrition (13±5 Kcal/kg-1/day-1) will be started. After the start of insulin infusion protocol a glycemic control will be provided every hour in order to obtain three consecutive values that were within the goal range. The infusion will be lasted until stable glycemic goal (80-140 mg/dl) at least for 24 h. After glycemic goal will be maintained for 24 h, a parenteral nutrition was stopped and feeding will be started according to European guidelines. Subcutaneous insulin will be initiated at the cessation of the infusion. After discharge from the hospital, insulin will be given as short-acting insulin before meals and long-acting insulin in the evening for 30 days from PCI. The treatment goal will be a fasting blood glucose level of 90-140 mg/dl and a non-fasting level of <180 mg/dl.

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  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chest discomfort lasting at least 15 min within the last 24 h,
  • new >l mm ST-wave or dynamic T-wave changes in at least two contiguous ECG leads,
  • troponin I levels above the 99th percentile 6-12 h after the onset of chest pain
  • patients referred to the cardiac catheterization laboratory within 24 h of symptoms.

Exclusion Criteria:

  • left ventricular ejection fraction less than 25%,
  • hemorrhagic diatheses,
  • contraindications or allergy to aspirin, thienopyridines, and history of anaphylaxis in response to iodinated contrast medium,
  • serum creatinine level of more than 2.0 mg/dl (177 μmol/l),
  • leukocyte count of less than 3500/mm3, platelet count of less than 100,000/mm3
  • coexisting conditions that limited life expectancy to less than 24 months or that could affect a patient's compliance with the protocol.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01016509

Locations
Italy
Dept Geriatric and Metabolic diseases SUN
Naples, Italy, 80138
Sponsors and Collaborators
Second University of Naples
Investigators
Principal Investigator: Raffaele Marfella, MD, PhD Second University of Naples
  More Information

No publications provided by Second University of Naples

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raffaele Marfella, Assistant Professor, Second University of Naples
ClinicalTrials.gov Identifier: NCT01016509     History of Changes
Other Study ID Numbers: IT 246813
Study First Received: November 18, 2009
Last Updated: December 20, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Second University of Naples:
restenosis
insulin
hyperglycemia

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014