Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography

Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography With or Without Percutaneous Coronary Intervention

There are 24 million people with diabetes mellitus (DM) in the United States. Over one-third of patients presenting for coronary angiography have known DM, and an additional 20% of patients without known DM present with hyperglycemia on the day of coronary angiography. Hyperglycemia in the setting of urgent and elective percutaneous coronary intervention (PCI) is associated with a 40% relative increase in long-term mortality regardless of diabetic status. Mechanisms linking periprocedural hyperglycemia to adverse outcomes are poorly understood and the effects of treatment are unknown. This is a pilot study aimed at determining the effectiveness, feasibility and safety of continuing long-acting hypoglycemic medications on the morning of coronary angiography. Since hyperglycemia may cause increased platelet reactivity, a secondary aim is to evaluate a possible mechanism of benefit of periprocedural glycemic control on platelet activity. Patients with DM on hypoglycemic medications undergoing coronary angiography will be randomized to either continue or hold their clinically-prescribed long-acting hypoglycemic medications on the day of procedure. Patients with and without DM will be randomized to either routine care or additional glycemic control with the Yale insulin infusion protocol for 6 hours post-PCI. The primary endpoint of this study will be mean blood glucose level at the time of arterial access in the hold versus continue groups. Secondary endpoints will be mean blood glucose level at 6 hours post-PCI in the Yale versus routine care groups and number of hypoglycemic events in the glycemic control versus no glycemic control groups. The exploratory analysis assessing the effect of glycemic control on platelet activity will guide further studies evaluating the translation of an individual's platelet phenotype to the clinical risk of increased long-term mortality following PCI. The outcomes for this study (glucose levels and platelet function) are all measured during the hospital stay which averages 1 day.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Intervention / Treatment: Other: hold hypoglycemic meds

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • VA New York Harbor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients undergoing coronary angiography at the Manhattan Campus of the VA NY Harbor Healthcare System

Exclusion Criteria:

• 1. Patients who do not or are unable to consent. 2. Patients participating in a competing study. 3. For platelet substudy, patients who took NSAIDs within 72 hours of blood collection or who are on cilostazol or dipyridamole as part of their routine medication regimen. 4. Patients with any other co-morbidities that would influence subject safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: continue hypglycemic meds	Other: hold hypoglycemic meds; continue versus hold hypoglycemic medications
No Intervention: control - hold drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
periprocedural glucose	measure of blood glucose when cardiac catheterization begins at the time of arterial access	within 12 hours of randomization

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 17, 2011
• First Posted (Estimate): August 18, 2011

Study Record Updates

• Last Update Posted (Estimate): June 12, 2012
• Last Update Submitted That Met QC Criteria: June 8, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Hypoglycemic Agents
• Other Study ID Numbers: bds1