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 range18 Years

SexALL

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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 …

What they're measuring

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

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

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

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

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

Trial details

NCT IDNCT04052763

SponsorCentre Hospitalier Universitaire Vaudois

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-04-01

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