Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis

NCT01016509 | Completed DMC

• 1 other identifier: IT 246813
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

restenosis; insulin; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Coronary angiograms

  at baseline, immediately after PCI, and at 6 months

Secondary Outcomes (1)

• IVUS Imaging

  at baseline, immediately after PCI, and at 6 months

Study Arms (3)

control

NO INTERVENTION

No hyperglycemia patient group

Insulin 1

ACTIVE COMPARATOR

Conventional insulin treatment

Drug: Insulin

Insulin

EXPERIMENTAL

Intensive insulin treatment

Drug: Insulin

Interventions

Insulin DRUG

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.

Insulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Dept Geriatric and Metabolic diseases SUN

Naples, Italy, 80138, Italy

Location

Related Publications (2)

• Marfella R, Rizzo MR, Siniscalchi M, Paolisso P, Barbieri M, Sardu C, Savinelli A, Angelico N, Del Gaudio S, Esposito N, Rambaldi PF, D'Onofrio N, Mansi L, Mauro C, Paolisso G, Balestrieri ML. Peri-procedural tight glycemic control during early percutaneous coronary intervention up-regulates endothelial progenitor cell level and differentiation during acute ST-elevation myocardial infarction: effects on myocardial salvage. Int J Cardiol. 2013 Oct 9;168(4):3954-62. doi: 10.1016/j.ijcard.2013.06.053. Epub 2013 Jul 19.

  PMID: 23876463 DERIVED

• Marfella R, Sasso FC, Siniscalchi M, Paolisso P, Rizzo MR, Ferraro F, Stabile E, Sorropago G, Calabro P, Carbonara O, Cinquegrana G, Piscione F, Ruocco A, D'Andrea D, Rapacciuolo A, Petronella P, Bresciani A, Rubino P, Mauro C, Paolisso G. Peri-procedural tight glycemic control during early percutaneous coronary intervention is associated with a lower rate of in-stent restenosis in patients with acute ST-elevation myocardial infarction. J Clin Endocrinol Metab. 2012 Aug;97(8):2862-71. doi: 10.1210/jc.2012-1364. Epub 2012 May 25.

  PMID: 22639289 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Hyperglycemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Raffaele Marfella, MD, PhD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

IT (1)