Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01419652 · ClinicalTrials.gov registry record · Phase 4
Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography
A Phase 4 study of Coronary Artery Disease and Diabetes Mellitus, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 351
- Enrollment target
- 1
- Study location
NCT01419652 is a Phase 4 study of Coronary Artery Disease and Diabetes Mellitus that has completed, run by NYU Langone Health. The registered enrollment target is 351 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01419652, a Phase 4 study of Coronary Artery Disease and Diabetes Mellitus, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 351 participants
- Enrollment target
- 1
- Study location
Study 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 du
Conditions Studied
Interventions
- OTHER hold hypoglycemic meds
Study Locations (1)
New York
- VA New York Harbor - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2009-07 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01419652
The ClinicalTrials.gov registry entry for NCT01419652 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (73% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which hold hypoglycemic meds is the first listed.
NCT01419652 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01419652 about?
NCT01419652 is a clinical study titled "Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography". 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 o...
What is the current status of trial NCT01419652?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 351 participants. The study started on 2009-07. Estimated completion is 2012-06.
What conditions does trial NCT01419652 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Diabetes Mellitus.
What interventions are being tested in trial NCT01419652?
The interventions under investigation include: hold hypoglycemic meds (OTHER).
Who is sponsoring clinical trial NCT01419652?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01419652 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI
RECRUITING · Phase 4
-
The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
RECRUITING · Phase 4
-
Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: The Switching Antiplatelet-8 (SWAP-8) Study
RECRUITING · Phase 4
-
Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention
RECRUITING · Phase 4
-
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
RECRUITING · Phase 4
-
Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors
RECRUITING · Phase 4
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.