Viewing Study NCT00250185



Ignite Creation Date: 2024-05-05 @ 12:09 PM
Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00250185
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2005-11-05

Brief Title: The Role of Nitrite in Preconditioning Mediated Tolerance to Ischemic Stress
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: The Role of Nitrite in Preconditioning Mediated Tolerance to Ischemic Stress
Status: COMPLETED
Status Verified Date: 2008-08-22
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
06-H-0024 None None None