Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Sedlis, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01419652
First received: August 12, 2011
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Coronary Artery Disease
Other: hold hypoglycemic meds
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography With or Without Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • periprocedural glucose [ Time Frame: within 12 hours of randomization ] [ Designated as safety issue: Yes ]
    measure of blood glucose when cardiac catheterization begins at the time of arterial access


Enrollment: 351
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: continue hypglycemic meds Other: hold hypoglycemic meds
continue versus hold hypoglycemic medications
No Intervention: control - hold drug

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01419652

Locations
United States, New York
VA New York Harbor
New York, New York, United States, 10010
Sponsors and Collaborators
New York University School of Medicine
  More Information

No publications provided

Responsible Party: Steven Sedlis, Chief, Cardiology VA NYHHCS New York campus, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01419652     History of Changes
Other Study ID Numbers: bds1
Study First Received: August 12, 2011
Last Updated: June 8, 2012
Health Authority: United States:Department of Veterans Affairs

Keywords provided by New York University School of Medicine:
percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014