Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography

NCT ID: NCT01419652

Last Updated: 2012-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

Conditions

Diabetes Mellitus; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

continue hypglycemic meds

Group Type: ACTIVE_COMPARATOR

hold hypoglycemic meds

Intervention Type: OTHER

continue versus hold hypoglycemic medications

control - hold drug

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

hold hypoglycemic meds

continue versus hold hypoglycemic medications

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Steven Sedlis

Chief, Cardiology VA NYHHCS New York campus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA New York Harbor

New York, New York, United States

Countries

United States

Other Identifiers

bds1

Identifier Type: -

Identifier Source: org_study_id