A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice (NCT04700397) | Clinical Trial Compass
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A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice
Taiwan100 participantsStarted 2021-01-02
Plain-language summary
Hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eligible for FFR examination
Exclusion Criteria:
* Hypersensitivity to adenosine or nitroglycerine
* Severe Valvular aortic stenosis
* Resting heart rate less than 50 beats per minutes
* Systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 40 mmHg
* exposure to PDE-5 inhibitors within 48 hours.
* Recent intracranial hemorrhage or brain injury
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether nitroglycerin can reliably cause a temporary drop in blood pressure to measure heart artery function — given that I already have symptomatic hypotension, is that kind of intentional blood pressure drop safe for me to undergo?
2The trial is described as 'phase NA,' which suggests it's a validation or measurement study rather than a treatment trial — can you explain what that means for me practically, and what I would actually experience if I took part?
3Since the trial's recruitment status is listed as unknown, is it even currently enrolling patients, and how would we find out if it's still an option worth pursuing?
4This study is focused on testing the repeatability and reliability of a measurement technique rather than offering a new treatment — would participating in it have any direct benefit for managing my ischemic heart disease, or is it purely for research purposes?
5Are there standard diagnostic tests already available to assess my coronary artery function that might give my care team the information they need without me enrolling in a research study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The repeatability and dose response of NTG-Pd/Pa
Timeframe: 10 minutes
Trial details
NCT IDNCT04700397
SponsorNational Taiwan University Hospital Hsin-Chu Branch