Status:
TERMINATED
FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Brief 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 steno...
Detailed Description
Study Design and Procedure: The present study is a single arm, double blinded, prospective trial. Patients admitted to hospital with high-risk non-ST elevation acute coronary syndrome (NSTE-ACS) and ...
Eligibility Criteria
Inclusion
- 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 with prior coronary artery bypass grafting (CABG)
- Patient with known severe heart failure (i.e Ejection fraction of left ventricle of \<30%)
- Patient incapable of judgement or under tutelage
Exclusion
Key Trial Info
Start Date :
August 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04052763
Start Date
August 28 2019
End Date
January 1 2024
Last Update
August 7 2024
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011