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NCT00069654 · ClinicalTrials.gov registry record · Phase 2
Dietary Nitrate and Nitrite to Increase Nitric Oxide in Patients With Coronary Artery Disease
A Phase 2 study of Coronary Arteriosclerosis, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00069654 is a Phase 2 study of Coronary Arteriosclerosis that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 42 participants, below the 714-participant average among 11 other Coronary Arteriosclerosis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00069654, a Phase 2 study of Coronary Arteriosclerosis, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine whether dietary nitrates and nitrites can produce nitric oxide in the body and dilate blood vessels in patients with coronary artery disease. Nitric oxide is normally made by endothelial cells that line blood vessels. It plays an important role in maintaining the normal function of arteries by keeping them open and preventing damage from substances such as cholesterol in the blood stream. Coronary artery disease is caused by atherosclerosis (hardening of the arteries or build-up of cholesterol and scar tissue within the walls of the arteries). Once arteries become clogged, the ability of the endothelium to produce nitric oxide diminishes considerably and may speed up the disease process, leading to shortness of breath, chest pain, and an increased risk of heart attack or stroke. Patients 21 years of age and older with coronary artery disease may be eligible for this study. Participants will have a medical history and physical examination, electrocardiogram (recording of the electrical activity of the heart), echocardiogram (ultrasound test of the heart), treadmill exercise stress test (see below), and will meet with a dietitian. They will be hospitalized at the NIH Clinical Center on two occasions. For 1 week before each admission, they will follow a diet prescribed by an NIH nutritionist. The diet before one admission will be high in nitrates and nitrites, and the diet before the other admission will be low in nitrates and nitrites. Each admission will last 4 days, during which participants will undergo the following tests: * Forearm blood flow study: Small tubes are placed in the artery and vein at the inside of the elbow of the dominant arm (right- or left-handed) and a small tube is placed in a vein of the other arm. The tubes are used for infusing saline (salt water) and for drawing blood samples. A pressure cuff is placed around the upper part of the dominant arm, and a rubber band device called a strain gauge is also placed around
Conditions Studied
Interventions
- PROCEDURE Forearm blood flow study
- PROCEDURE Brachial artery reactivity study
- PROCEDURE Treadmill exercise test
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2003-09-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069654
The ClinicalTrials.gov registry entry for NCT00069654 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 714-participant average among 11 other Coronary Arteriosclerosis trials with a reported enrollment target (94% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Coronary Arteriosclerosis appearing as the primary indexed condition, and to 3 interventions - of which Forearm blood flow study is the first listed.
NCT00069654 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00069654 about?
NCT00069654 is a clinical study titled "Dietary Nitrate and Nitrite to Increase Nitric Oxide in Patients With Coronary Artery Disease". This study will determine whether dietary nitrates and nitrites can produce nitric oxide in the body and dilate blood vessels in patients with coronary artery disease. Nitric oxide is normally made by endothelial cells that line blood vessels. It plays an important role in maintaining the normal fun...
What is the current status of trial NCT00069654?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2003-09-25.
What conditions does trial NCT00069654 study?
This clinical trial studies the following conditions: Coronary Arteriosclerosis.
What interventions are being tested in trial NCT00069654?
The interventions under investigation include: Forearm blood flow study (PROCEDURE), Brachial artery reactivity study (PROCEDURE), Treadmill exercise test (PROCEDURE).
Who is sponsoring clinical trial NCT00069654?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00069654 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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