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NCT00250185 · ClinicalTrials.gov registry record · Phase 1
The Role of Nitrite in Preconditioning Mediated Tolerance to Ischemic Stress
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 135
- Enrollment target
NCT00250185: Completed Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00250185 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 135 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00250185, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 135 participants
- Enrollment target
Study Summary
Many studies have shown that if the human body is stressed by a lack of blood flow for a short period of time, the body develops defenses to make the body more resistant to a future stress from lack of blood flow. This natural defense system is called preconditioning. Finding medications that have a preconditioning effect to protect against damage from loss of blood flow would be of great help in the treatment of diseases such as heart attacks and stroke that occur because of blockages of blood flow. Predicting future heart attacks or strokes is very difficult and makes it difficult to study medications that could have a preconditioning effect. However, it has recently been recognized that we can mimic the preconditioning effect in the human arm, by blocking blood flow using a blood pressure cuff under pressure. Here, blowing up the cuff for 5 minutes and then letting the pressure out for 5 minutes and repeating this process twice more (a way to precondition the arm), has been shown to improve blood vessel function in response to a longer period of blood pressure cuff inflation (20 minutes). As nitrite, a naturally occurring blood substance, has biological effects suggesting that it may mimic preconditioning. The main objective of this study is to assess whether nitrite is equivalent to preconditioning in its capacity to protect the forearm blood flow in response to a 20 minute blockage of blood flow by blood pressure cuff inflation of the forearm. We hypothesize that in human subjects the ischemic preconditioning program works through activation of the pool of nitrite in the blood stream. Moreover, we propose that nitrite treatment will improve (1) blood vessel recovery (2) skeletal muscle blood flow and (3) skeletal muscle mitochondrial function and (4) reduce the activation of inflammation in response to the 20 minute stress of blood pressure cuff inflation.
Interventions
- DRUG Acetylcholine
- DRUG Sodium Nitrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2005-11-01 |
| Est. Completion | 2007-06-09 |
| Phase | Phase 1 |
What the finished NCT00250185 record still lists
NCT00250185 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 2 interventions - of which Acetylcholine is the first listed.
NCT00250185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00250185 about?
NCT00250185 is a clinical study titled "The Role of Nitrite in Preconditioning Mediated Tolerance to Ischemic Stress". Many studies have shown that if the human body is stressed by a lack of blood flow for a short period of time, the body develops defenses to make the body more resistant to a future stress from lack of blood flow. This natural defense system is called preconditioning. Finding medications that have a...
What is the current status of trial NCT00250185?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2005-11-01. Estimated completion is 2007-06-09.
What interventions are being tested in trial NCT00250185?
The interventions under investigation include: Acetylcholine (DRUG), Sodium Nitrate (DRUG).
Who is sponsoring clinical trial NCT00250185?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00250185's enrollment target sits among peer trials
135 425th of 2000 higher than 1,574 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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