CompletedNot Applicable

DSE vs. FFR in SCAD and BYSTANDER Lesions

200 participantsStarted 2014-12-01

Plain-language summary

Enrollment: * Patients with stable coronary artery disease (SCAD) and moderate coronary artery stenoses (30-70 %) * Patients with acute myocardial infarction and moderate stenosis of non-culprit arteries (NCL; BYSTANDER LESION) Aims: * To assess the diagnostic accuracy of dobutamine stress echocardiography (DSE) and invasive fractional flow reserve (FFR) measurement * To assess the prognostic impact of reclassification by a mismatching negative test Hypothesis: * DSE and FFR have similar prognostic value in both clinical settings (SCAD and NCL) * Considering the strong negative predictive value of both DSE and FFR, one negative test is sufficiently enough to defer revascularisation, even in the case of mismatch

Who can participate

Age range

18 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: * Age\>18 years * Moderate Coronary Stenosis (30-70 %) * Stable coronary artery disease or patients with acute myocardial infarction and at least one moderate non-culprit vessel stenosis Exclusion Criteria: * Left Main Coronary artery stenosis * Age\>80 years * Known non-cardiovascular disease with poor prognosis * Patients for whom coronary angiography or stress echocardiography is contraindicated per institutional standard of care (e.g. History of severe and/or anaphylactic contrast reaction) * Inability to provide informed consent; * Inability to cooperate with the investigation * Pregnancy

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.

What they're measuring

Acute Myocardial Infarction

Timeframe: From baseline to at least 2 years

Target Vessel Revascularisation

Timeframe: From baseline to at least 2 years

Cardiovascular Death

Timeframe: From baseline to at least 2 years

Trial details

NCT IDNCT03383718

SponsorBajcsy-Zsilinszky Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12-01

View on ClinicalTrials.gov More Ischemic Heart Disease trials

Plain-language summary

Who can participate

Age range

18 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.