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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: Completed Phase 4 study of Coronary Artery Disease and Diabetes Mellitus, sponsored by NYU Langone Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
measure of blood glucose when cardiac catheterization begins at the time of arterial access
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 |
What the finished NCT01419652 record still lists
NCT01419652 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (73% lower).
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 a single indexed study location in 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
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Where NCT01419652's enrollment target sits among peer trials
351 95th of 219 higher than 125 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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