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Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis

NCT01016509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-12-21

No results posted yet for this study

Summary

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.

Conditions

  • Restenosis
  • Tight Glycemic Control

Interventions

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.

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.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Raffaele Marfella, MD, PhD · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01016509 on ClinicalTrials.gov