Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography

NCT01419652 | Completed Phase 4

• 1 other identifier: bds1
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

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

Keywords

percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• periprocedural glucose

  measure of blood glucose when cardiac catheterization begins at the time of arterial access

  within 12 hours of randomization

Study Arms (2)

continue hypglycemic meds

ACTIVE COMPARATOR

Other: hold hypoglycemic meds

control - hold drug

NO INTERVENTION

Interventions

hold hypoglycemic meds OTHER

continue versus hold hypoglycemic medications

continue hypglycemic meds

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

VA New York Harbor

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiology VA NYHHCS New York campus

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 18, 2011
• Study Start: July 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

US (1)