FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Ac… (NCT04052763) | Clinical Trial Compass
TerminatedNot Applicable
FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome
Stopped: Slow enrolment during the COVID pandemics
Switzerland164 participantsStarted 2019-08-28
Plain-language summary
The present study is a monocentric, observational, single arm, study, with the aim to determinate the ability of FFR-CT to exclude or confirm the presence of hemodynamically significant coronary stenosis, compared to coronary angiography in high-risk acute coronary syndrome patients.
Who can participate
Age range
18 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:
* ≥18 years old patients
* Presenting a rise and/or fall of high-sensitive cardiac troponins T (hs-cTnt) values measured in Centre Hospitalier Universitaire Vaudois (CHUV) on at least 2 timepoints with at least one value above the 99th percentile of the upper range limit (URL) and with at least one of the following:
* Symptoms of ischemia
* New or presumed new significant ST-segment-T wave (ST-T) changes
* Informed consent signed
* Presumed availability for follow-up up to 1 year (i.e. patients only transiting through Switzerland for travel purpose are de facto excluded)
* Was transferred from CHUV Emergency Department to the CHUV Cardiology Service according to the fast-track institutional procedure
Exclusion criteria:
* STEMI patients
* Estimated glomerular filtration rate (eGFR) of \<45 ml/min
* Presence of very high-risk criteria:
* Hemodynamic instability or cardiogenic shock
* Recurrent or ongoing chest pain refractory to medical treatment
* Life-threatening arrhythmias or cardiac arrest
* Mechanical complications of myocardial infarction
* Acute heart failure
* Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation
* Pregnant and breast-feeding women (women of child bearing potential must have a negative urine or blood pregnancy at screening)
* Contra-indication to beta-blocker and/or nitroglycerin
* Patients transferred from another hospital where diagnosis was made using a troponin dosage other than hs-cTnT
* Patients …
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
1
Negative predictive value of FFR-CT to detect the absence of hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
Timeframe: Through inclusion completion, expected after 18 months of enrolment
2
Accuracy of FFR-CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
Timeframe: Through inclusion completion, expected after 18 months of enrolment
3
Sensitivity of FFR-CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
Timeframe: Through inclusion completion, expected after 18 months of enrolment
4
Specificity of FFR-CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
Timeframe: Through inclusion completion, expected after 18 months of enrolment
5
Positive predictive value of FFR-CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
Timeframe: Through inclusion completion, expected after 18 months of enrolment