TerminatedNo phase
FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome
Key facts
- Who runs it
- Centre Hospitalier Universitaire Vaudois
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 164 people enrolled
- Started
- 28 Aug 2019
- Ended
- 1 Jan 2024
- Type of study
- Observational
- Treatments tested
- FFR-CT
- FFRangio™
- Record updated
- 7 August 2024
- Why it stopped
- Slow enrolment during the COVID pandemics
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- ≥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
Who cannot take part
- Patients with prior coronary artery bypass grafting (CABG)
- Life-threatening arrhythmias or cardiac arrest
- Mechanical complications of myocardial infarction
- Acute heart failure
- Estimated glomerular filtration rate (eGFR) of <45 ml/min
- Patient with known severe heart failure (i.e Ejection fraction of left ventricle of <30%)
- STEMI patients
- Presence of very high-risk criteria:
- Hemodynamic instability or cardiogenic shock
- Recurrent or ongoing chest pain refractory to medical treatment
- 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
- Patient incapable of judgement or under tutelage
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- High-risk ACS patients
High-risk ACS patients admitted to the emergency departement witch chest pain.
Treatment: FFR-CT and FFRangio™
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ability of FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome Admitted in the Emergency Department With Chest Pain: a Diagnostic Accuracy Prospective Study
- Record updated
- 7 August 2024