Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR) (NCT03570671) | Clinical Trial Compass
UnknownNot Applicable
Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)
South Korea90 participantsStarted 2018-03-01
Plain-language summary
With regard to the characteristics of spasm segment, had been clearly described by other invasive imaging methods including intravascular ultrasound and optical coherence tomography. However, there is potential risk during these invasive procedures, such as severe myocardial ischemia or fatal arrhythmia.
Presently available imaging test for coronary artery disease in multi detector-row computed tomography angiography (MDCTA) evaluation has high diagnostic accuracy to evaluate coronary artery stenosis. However, previous report assessing imaging findings or diagnostic accuracy of MDCTA in patients with vasospastic angina (VSA) is lacking.
Who can participate
Age range
20 Years – 80 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:
* Subject is onset of angina-like attack at rest, during effort, or during rest and effort.
* Subject has chest pain between night and early morning.
* Subject is scheduled to undergo MDCTA.
* Subject is an acceptable candidate for CAG with an EG provocation test.
* Cardiac condition: BP\>90/60mmHg, ECG: sinus rhythm with regular, left ventricular ejection fraction\>55%, and resting heart rate\<100 beats/min.
* Subject will be provided written informed consent.
* Subject is willing to comply with study follow-up requirement.
Exclusion Criteria:
* Subject has clinical evidence of acute coronary syndrome.
* Subject has evidence of significant narrowing (\>50% stenosis by CAG).
* Subject has clinical evidence of cardiomyopathy or valvular heart disease.
* Subject is hemodynamically unstable.
* Subject has a history of PCI and CABG.
* Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
* Subject has known allergy to contrast medium.
* Subject has renal insufficiency (serum creatine \>2.5 mg/dl).
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.