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NCT00014040 · ClinicalTrials.gov registry record · Phase 2
Nitric Oxide Inhalation Therapy to Relieve Chest Pain in Patients With Coronary Artery Disease
A Phase 2 study of Coronary Disease and Myocardial Ischemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00014040 is a Phase 2 study of Coronary Disease and Myocardial Ischemia that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 25 participants, below the 2,019-participant average among 34 other Coronary Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00014040, a Phase 2 study of Coronary Disease and Myocardial Ischemia, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test whether inhaling nitric oxide gas can improve blood flow to the heart, ventricular function, exercise tolerance in patients with coronary artery disease and chest pain that has not improved with medical or surgical therapy. Patients with coronary artery disease who have chest pain despite treatment with medicines and angioplasty or surgery may be eligible for this study. Those enrolled will receive monetary compensation for their participation in this study. The duration of the study is 5 days, with 2 testing periods lasting 2 days each. During one of the periods, the study participants will breathe nitric oxide mixed with room air through a face mask during the tests. During the other period, the participants will breathe room air alone through a face mask during the tests. At least 1 day will separate the treatment periods. During each of the 2 treatment periods (nitric oxide and room air), participants will undergo 4 tests to determine whether the treatment improves the heart's response to stress with increased heart rate and contraction. Approximately one hour before each of the tests, participants will breathe either nitric oxide mixed with room air or room air alone through the face mask, and continue the inhalation treatment while each test is being performed. The face mask will be removed at the end of each test. On the morning of the first day of each treatment period, participants will have a special echocardiogram with imaging of the heart. The echocardiogram will be performed during an infusion of dobutamine, a medicine that increases heart rate and contraction, and serves to stress the heart. This manner of stress testing is commonly used in hospitals around the country to determine if walls of the heart are receiving sufficient blood supply. That afternoon, participants will undergo a magnetic resonance imaging (MRI) study of the heart. The MRI will determine the heart's blood flow and contraction while receiving the same dosage
Conditions Studied
Interventions
- DRUG Nitric Oxide and INOpulse Delivery System
Study Locations (1)
Maryland
- National Heart, Lung and Blood Institute (NHLBI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2001-04 |
| Est. Completion | 2003-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00014040
The ClinicalTrials.gov registry entry for NCT00014040 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,019-participant average among 34 other Coronary Disease trials with a reported enrollment target (99% 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 2 conditions, with Coronary Disease appearing as the primary indexed condition, and to 1 intervention - of which Nitric Oxide and INOpulse Delivery System is the first listed.
NCT00014040 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00014040 about?
NCT00014040 is a clinical study titled "Nitric Oxide Inhalation Therapy to Relieve Chest Pain in Patients With Coronary Artery Disease". This study will test whether inhaling nitric oxide gas can improve blood flow to the heart, ventricular function, exercise tolerance in patients with coronary artery disease and chest pain that has not improved with medical or surgical therapy. Patients with coronary artery disease who have chest p...
What is the current status of trial NCT00014040?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2001-04. Estimated completion is 2003-04.
What conditions does trial NCT00014040 study?
This clinical trial studies the following conditions: Coronary Disease, Myocardial Ischemia.
What interventions are being tested in trial NCT00014040?
The interventions under investigation include: Nitric Oxide and INOpulse Delivery System (DRUG).
Who is sponsoring clinical trial NCT00014040?
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 NCT00014040 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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