Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109018
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-04-21
Brief Title:
Biomarkers for Cardiovascular Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Nitrite as a Marker of Cardiovascular Risk Development of Novel Biomarkers in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2009-04-15
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:
Biomarkers for Cardiovascular Disease
Summary This study will examine the function of the lining cells of blood vessels and measure substances in the blood to see how they relate to various blood tests including new tests under development to determine cardiovascular disease risk Nitric oxide is a molecule produced by healthy blood vessels that helps keep them relaxed Nitrate is a substance formed from nitric oxide in the blood The release of nitric oxide by blood vessels is reduced in patients with coronary artery disease compared with healthy people Also blood nitrite levels rise in some of these patients Other substances in the blood and urine also change with risk for heart disease This study will measure nitrite levels and other inflammatory substances in the blood and urine
Healthy volunteers people with various risk factors for heart disease and people with blockage of one or more major heart arteries or a history of heart attack may be eligible for this study Candidates must be 21 years of age or older People who have an irregular heart rhythm or who cannot take oral nitrates are excluded
Participants undergo the following tests and procedures
Blood tests Samples are drawn three times for routine tests and to look for certain proteins that may affect the heart Samples are collected once before any other tests once before starting the exercise stress test see below and again after the stress test
Urine test A sample may be tested for proteins in the urine and for other research studies
Brachial artery reactivity study This ultrasound study tests how well a persons arteries widen The subject rests on a bed An ultrasound measuring device is placed over the artery just above the elbow The size of the artery and blood flow through it are measured before and after inflating a pressure cuff around the forearm The pressure cuff stops the flow of blood to the arm for 5 minutes and then is released while more ultrasound pictures are taken After the subject rests a nitroglycerin tablet medicine that causes blood vessels to relax is placed under the tongue After the nitroglycerin is given the size of the artery and blood flow through it are measured again After a rest period the study will be repeated in the healthy volunteers and first 20 patients with heart disease
Echocardiography heart ultrasound This test involves holding a small probe against the chest to use sound waves for obtaining pictures of the heart A small catheter plastic tube may be placed in a vein to inject a contrast agent that enhances the pictures
Metabolic stress testing Subjects will be asked to breathe in and out of a mask while baseline measurements are taken Then they exercise on a treadmill while wearing a breathing mask This test shows how much oxygen the body uses at rest and with exercise
Genetic testing optional A blood sample is collected to examine DNA - genetic material that determines inherited traits and contains information about body proteins Some parts of DNA may be used as markers of the level of damage produced by oxygen by-products that may reflect the extent of heart disease in patients Also gene variations may make an individual more likely to develop a heart problem Such markers may guide doctors in predicting how fast the disease will progress or may help find a new type of drug to prevent disease
Time requirements This study is expected to take approximately 5-6 hours for completion within one or two days
Follow-up Patients are contacted by phone every 6 months for information on chest pain surgical procedures related to the heart and hospitalizations
Summary This study will examine the function of the lining cells of blood vessels and measure substances in the blood to see how they relate to various blood tests including new tests under development to determine cardiovascular disease risk Nitric oxide is a molecule produced by healthy blood vessels that helps keep them relaxed Nitrate is a substance formed from nitric oxide in the blood The release of nitric oxide by blood vessels is reduced in patients with coronary artery disease compared with healthy people Also blood nitrite levels rise in some of these patients Other substances in the blood and urine also change with risk for heart disease This study will measure nitrite levels and other inflammatory substances in the blood and urine
Healthy volunteers people with various risk factors for heart disease and people with blockage of one or more major heart arteries or a history of heart attack may be eligible for this study Candidates must be 21 years of age or older People who have an irregular heart rhythm or who cannot take oral nitrates are excluded
Participants undergo the following tests and procedures
Blood tests Samples are drawn three times for routine tests and to look for certain proteins that may affect the heart Samples are collected once before any other tests once before starting the exercise stress test see below and again after the stress test
Urine test A sample may be tested for proteins in the urine and for other research studies
Brachial artery reactivity study This ultrasound study tests how well a persons arteries widen The subject rests on a bed An ultrasound measuring device is placed over the artery just above the elbow The size of the artery and blood flow through it are measured before and after inflating a pressure cuff around the forearm The pressure cuff stops the flow of blood to the arm for 5 minutes and then is released while more ultrasound pictures are taken After the subject rests a nitroglycerin tablet medicine that causes blood vessels to relax is placed under the tongue After the nitroglycerin is given the size of the artery and blood flow through it are measured again After a rest period the study will be repeated in the healthy volunteers and first 20 patients with heart disease
Echocardiography heart ultrasound This test involves holding a small probe against the chest to use sound waves for obtaining pictures of the heart A small catheter plastic tube may be placed in a vein to inject a contrast agent that enhances the pictures
Metabolic stress testing Subjects will be asked to breathe in and out of a mask while baseline measurements are taken Then they exercise on a treadmill while wearing a breathing mask This test shows how much oxygen the body uses at rest and with exercise
Genetic testing optional A blood sample is collected to examine DNA - genetic material that determines inherited traits and contains information about body proteins Some parts of DNA may be used as markers of the level of damage produced by oxygen by-products that may reflect the extent of heart disease in patients Also gene variations may make an individual more likely to develop a heart problem Such markers may guide doctors in predicting how fast the disease will progress or may help find a new type of drug to prevent disease
Time requirements This study is expected to take approximately 5-6 hours for completion within one or two days
Follow-up Patients are contacted by phone every 6 months for information on chest pain surgical procedures related to the heart and hospitalizations
Detailed Description:
Cardiovascular events are a major cause of morbidity and mortality world-wide and traditional risk factor assessment is limited in its ability to predict which patients will have an event The endothelium is known to play a central role in vascular homeostasis and nitric oxide NO is believed to be the main component responsible for normal endothelial function Increasing evidence suggests that oxidative stress leading to reduced NO bioavailability and subsequent endothelial dysfunction is an important factor in the progression of vascular diseases Further investigation of NO metabolites in blood may provide insight into the mechanisms of endothelial dysfunction and disease progression Preliminary data suggest that although plasma nitrite levels are decreased in CAD patients and correlate with endothelial dysfunction the nitrite within red blood cells and whole blood is compensatorily increased Since this new measure is more reproducible and convenient to measure it may serve as a biomarker of endothelial dysfunction A prospective study of nitrite and other novel NO-based assays proteomics and current biomarkers linked to endothelial function phenotype will allow further investigation into the pathophysiology of endothelial dysfunction and permit development of future markers of atherothrombosis
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 |
|---|---|---|---|
| 05-H-0145 | None | None | None |