Acute Coronary SyndromeNCT04052763
FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- FFR-CT and FFRangio™
- How many people
- 164 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Aug 2019to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-risk acute coronary syndrome patients admitted to the emergency departement
Who may be able to join
- ≥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 join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
About this study
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
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.
Read the 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 who accept to participate to the study will undergo a coronary compute tomography (CT) angiography within 23 hours after diagnosis in order to have time to proceed to coronary angiography within the recommended window time of 24h. After realization of the CT, they will benefit from guidelines recommended treatment including a coronary angiography. According to internal and international guidelines, all efforts will be made to perform the coronary angiography within 24h of acute coronary syndrome (ACS) diagnosis.
The coronary CT angiography procedure takes approximately 1-2h (including logistical organization and patient transportation), and all efforts will be made not to delay the coronary angiography compared to patients who would not participate in the study. At the time of coronary angiography, patients will be blinded from the CT results as well as the direct treating physician and interventional cardiologist realizing the procedure, in order to avoid any influence in patients' management. The procedure will be done using a 256-slice multi-detector CT (GE Healthcare Revolution CT, Chicago, Illinois, USA). Just before the examination, as routinely done for this non-invasive test to allow for optimal coronary vasodilation and visualization, oral Metoprolol (25-50mg) will be administered if necessary to ensure a heart rate of 65 bpm or lower as well as one unique dose of sublingual nitroglycerine (400-800mg). Parameters used for CT acquisition will be as following: 100 Kilovoltage peak (kVp)/550 milliamperes (mA) for body mass index (BMI) <25 (high definition mode), 100 kVp/550 mA for BMI included between 25 and 30, 120 kVp/600 mA for BMI>30 (standard definition mode). Off line, an FFR-CT will be calculated with the data of the coronary CT angiography by blinded investigators in a central FFR-CT core laboratory (HeartFlow ®, Redwood City, CA 94063, USA). Hemodynamically significant lesion will be defined as lesion with an FFR-CT value of ≤ 0.80.
During the invasive coronary angiography, fractional flow reserve (FFR) will be measured in all lesions with a visual diameter stenosis ≥30% using the PressureWire™ X Guidewire (Abbott, Chicago, Illinois, USA) with the following protocol: first, equalization of the pressure wire and the aortic pressure will be performed at the tip of the guide catheter prior to all measurements. Second, the pressure wire will then be advanced distal to the stenosis. Third, hyperemia will be obtained using intracoronary adenosine (150mcg for the right coronary artery and 200mcg for the left descending or the circumflex coronary arteries). Fourth, at the end of the procedure, the absence of a drift will be confirmed after a pull-back of the pressure to the same location as the initial equalization. Hemodynamically significant lesion will be defined as lesion with an FFR value of ≤ 0.80.
Of note, in case of coronary angiography showing no obstructive coronary disease, and thus not offering satisfactory explanation for the myocardial injury, patients will undergo cardiac magnetic resonance imaging (CMRI), to detect a potential alternative diagnosis (myocarditis, Takotsubo…).
Both invasive FFR and FFR derived from FFR-CT will be compared with invasive FFR as gold standard.
Follow-up:
Follow-up will be organized 1 month (± 7 days), 6 months (± 14 days) and 12 months (± 14 days) after the acute coronary syndrome. These visits will include a detailed history, as well as physical examination and ECG. During the second visit, a transthoracic echocardiography will be performed, and a treadmill exercise stress test will be performed during the third visit.
Data and Statistical Analysis:
Statistical analysis will be carried out using SPSS 24.0 software (SPSS Inc., Chicago, Illinois) and Stata 14.3. Comparisons of characteristics of patients will be performed using Chi-squared tests for qualitative variables and Student's t or Mann-Whitney tests as appropriate. Confidence intervals (CI) for proportions (sensitivity, specificity, accuracy) will be calculated using the Wilson Score method. With the last iteration of the FFR-CT software, the per-patient sensitivity and specificity were 86% (95% CI: 77% to 92%) and 79% (95% CI: 72% to 84%). In the recent VERDICT trial based on NSTEMI patients, 12 % had 3 vessel disease, 23 % 2 vessel disease (which included left main), 34%, 1 vessel disease, 30% nothing, Thus, out of 100 patients with 300 coronaries, we expect 106 (i.e. 36+46+34) vessels with a stenosis. Based on the FAMOUS NSTEMI trial, 60% of invasive FFR measurements of these stenoses were significant. Thus, with a standard error of 0,05, and for a power of 80%, 204 patients will be required. However, some of the CT will not be suitable for analysis and some patients will have to be excluded. Therefore, we plan to include 250 patients. Of note, these number is also in line with the literature investigating the accuracy of FFR-CT versus FFR in patients with stable coronary artery disease.
- Conditions
- Acute Coronary Syndrome
- Being tested
- FFR-CT, FFRangio™
- Keywords
- NSTE-ACS, FFR-CT, FFRangio™
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR-CTDiagnostic test
FFR-CT is a non invasive method using coronary CT images and 3 dimensional modelling to reconstruct coronary arteries and their stenoses, with subsequent calculation of fractional flow reserve (FFR) based on a mathematical algorithm.
FFRangio™Diagnostic test
Angiography-derived FFR (FFRangio™) uses coronary angiography images and a mathematical algorithm to reconstruct a 3 dimensional model of coronary arteries with calculation of FFR without the use of a pressure guide.
| Study group | Role | What they receive |
|---|---|---|
| High-risk ACS patients | High-risk ACS patients admitted to the emergency departement witch chest pain. Receives: Diagnostic Test: FFR-CT; Diagnostic Test: FFRangio™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through inclusion completion, expected after 18 months of enrolment
Secondary outcomes (25)
Correlation (goodness of fit) of FFR-CT to detect hemodynamically significant stenosis, compared to invasive FFR in lesions with at least a 30% stenosis
Measured: Through inclusion completion, expected after 18 months of enrolment
Negative predictive value of coronary 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
Measured: Through inclusion completion, expected after 18 months of enrolment
Accuracy of coronary 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
Measured: Through inclusion completion, expected after 18 months of enrolment
Sensibility of coronary 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
Measured: Through inclusion completion, expected after 18 months of enrolment
Specificity of coronary 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
Measured: Through inclusion completion, expected after 18 months of enrolment
Positive predictive value of coronary 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
Measured: Through inclusion completion, expected after 18 months of enrolment
Safety endpoint
Composite endpoint composed of: radiation dose received per patient, dose of iodinated contrast media received per patient, incidence of acute kidney failure defined as an increase of > 1.5x the baseline creatinine value 3 days after the coronary angiography, incidence of vascular complications related to the coronary angiogram, incidence of stroke, and incidence of MACEs (major adverse cardiac events)
Measured: Through inclusion completion, expected after 18 months of enrolment
Feasibility of an FFR-CT strategy in case of high-risk ACS, defined as the number of cases among enrolled patients where CT and FFR-CT is not feasible (moving artefacts, quality…)
Measured: Through inclusion completion, expected after 18 months of enrolment
Accuracy, of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Sensitivity of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Specificity of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Negative predictive value of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Positive predictive value of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Accuracy of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Sensitivity of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Specificity of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Negative predictive value of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Positive predictive value of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to invasive FFR in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to FFRangio™ in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to FFR-CT in high-risk ACS patients
Measured: Through inclusion completion, expected after 18 months of enrolment
Natural history of deferred lesions according to invasive FFR in term of major adverse cardiac events (MACE)
Measured: Through follow-up completion, expected 30 months after study initiation
Natural history of deferred lesions according to FFR-CT, in term of major adverse cardiac events (MACE)
Measured: Through follow-up completion, expected 30 months after study initiation
Natural history of deferred lesions according to CT in term of major adverse cardiac events (MACE)
Measured: Through follow-up completion, expected 30 months after study initiation
Natural history of deferred lesions according to FFRangio™ in term of major adverse cardiac events (MACE)
Measured: Through follow-up completion, expected 30 months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start28 Aug 2019
- Primary completion1 Apr 2022
- Study completion1 Jan 2024
Why it stopped: Slow enrolment during the COVID pandemics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephane Fournier, Centre Hospitalier Universitaire Vaudois
- Investigators
- Stephane Fournier, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052763
- Sponsor's protocol ID
- no defined yet
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2019
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04052763
- Acronym / sponsor ID
- no defined yet
- Conditions
- Acute Coronary Syndrome
- Keywords
- NSTE-ACS, FFR-CT, FFRangio™
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrolment during the COVID pandemics
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 who accept to participate to the study will undergo a coronary compute tomography (CT) angiography within 23 hours after diagnosis in order to have time to proceed to coronary angiography within the recommended window time of 24h. After realization of the CT, they will benefit from guidelines recommended treatment including a coronary angiography. According to internal and international guidelines, all efforts will be made to perform the coronary angiography within 24h of acute coronary syndrome (ACS) diagnosis.
The coronary CT angiography procedure takes approximately 1-2h (including logistical organization and patient transportation), and all efforts will be made not to delay the coronary angiography compared to patients who would not participate in the study. At the time of coronary angiography, patients will be blinded from the CT results as well as the direct treating physician and interventional cardiologist realizing the procedure, in order to avoid any influence in patients' management. The procedure will be done using a 256-slice multi-detector CT (GE Healthcare Revolution CT, Chicago, Illinois, USA). Just before the examination, as routinely done for this non-invasive test to allow for optimal coronary vasodilation and visualization, oral Metoprolol (25-50mg) will be administered if necessary to ensure a heart rate of 65 bpm or lower as well as one unique dose of sublingual nitroglycerine (400-800mg). Parameters used for CT acquisition will be as following: 100 Kilovoltage peak (kVp)/550 milliamperes (mA) for body mass index (BMI) <25 (high definition mode), 100 kVp/550 mA for BMI included between 25 and 30, 120 kVp/600 mA for BMI>30 (standard definition mode). Off line, an FFR-CT will be calculated with the data of the coronary CT angiography by blinded investigators in a central FFR-CT core laboratory (HeartFlow ®, Redwood City, CA 94063, USA). Hemodynamically significant lesion will be defined as lesion with an FFR-CT value of ≤ 0.80.
During the invasive coronary angiography, fractional flow reserve (FFR) will be measured in all lesions with a visual diameter stenosis ≥30% using the PressureWire™ X Guidewire (Abbott, Chicago, Illinois, USA) with the following protocol: first, equalization of the pressure wire and the aortic pressure will be performed at the tip of the guide catheter prior to all measurements. Second, the pressure wire will then be advanced distal to the stenosis. Third, hyperemia will be obtained using intracoronary adenosine (150mcg for the right coronary artery and 200mcg for the left descending or the circumflex coronary arteries). Fourth, at the end of the procedure, the absence of a drift will be confirmed after a pull-back of the pressure to the same location as the initial equalization. Hemodynamically significant lesion will be defined as lesion with an FFR value of ≤ 0.80.
Of note, in case of coronary angiography showing no obstructive coronary disease, and thus not offering satisfactory explanation for the myocardial injury, patients will undergo cardiac magnetic resonance imaging (CMRI), to detect a potential alternative diagnosis (myocarditis, Takotsubo…).
Both invasive FFR and FFR derived from FFR-CT will be compared with invasive FFR as gold standard.
Follow-up:
Follow-up will be organized 1 month (± 7 days), 6 months (± 14 days) and 12 months (± 14 days) after the acute coronary syndrome. These visits will include a detailed history, as well as physical examination and ECG. During the second visit, a transthoracic echocardiography will be performed, and a treadmill exercise stress test will be performed during the third visit.
Data and Statistical Analysis:
Statistical analysis will be carried out using SPSS 24.0 software (SPSS Inc., Chicago, Illinois) and Stata 14.3. Comparisons of characteristics of patients will be performed using Chi-squared tests for qualitative variables and Student's t or Mann-Whitney tests as appropriate. Confidence intervals (CI) for proportions (sensitivity, specificity, accuracy) will be calculated using the Wilson Score method. With the last iteration of the FFR-CT software, the per-patient sensitivity and specificity were 86% (95% CI: 77% to 92%) and 79% (95% CI: 72% to 84%). In the recent VERDICT trial based on NSTEMI patients, 12 % had 3 vessel disease, 23 % 2 vessel disease (which included left main), 34%, 1 vessel disease, 30% nothing, Thus, out of 100 patients with 300 coronaries, we expect 106 (i.e. 36+46+34) vessels with a stenosis. Based on the FAMOUS NSTEMI trial, 60% of invasive FFR measurements of these stenoses were significant. Thus, with a standard error of 0,05, and for a power of 80%, 204 patients will be required. However, some of the CT will not be suitable for analysis and some patients will have to be excluded. Therefore, we plan to include 250 patients. Of note, these number is also in line with the literature investigating the accuracy of FFR-CT versus FFR in patients with stable coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk ACS patients | – | Diagnostic Test: FFR-CT, Diagnostic Test: FFRangio™High-risk ACS patients admitted to the emergency departement witch chest pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-risk acute coronary syndrome patients admitted to the emergency departement
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFR-CTFFR-CT is a non invasive method using coronary CT images and 3 dimensional modelling to reconstruct coronary arteries and their stenoses, with subsequent calculation of fractional flow reserve (FFR) based on a mathematical algorithm. | Diagnostic test | High-risk ACS patients |
| FFRangio™Angiography-derived FFR (FFRangio™) uses coronary angiography images and a mathematical algorithm to reconstruct a 3 dimensional model of coronary arteries with calculation of FFR without the use of a pressure guide. | Diagnostic test | High-risk ACS patients |
Primary outcome
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through inclusion completion, expected after 18 months of enrolment
25 secondary outcomes
Correlation (goodness of fit) of FFR-CT to detect hemodynamically significant stenosis, compared to invasive FFR in lesions with at least a 30% stenosis
Time frame: Through inclusion completion, expected after 18 months of enrolment
Negative predictive value of coronary 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
Time frame: Through inclusion completion, expected after 18 months of enrolment
Accuracy of coronary 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
Time frame: Through inclusion completion, expected after 18 months of enrolment
Sensibility of coronary 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
Time frame: Through inclusion completion, expected after 18 months of enrolment
Specificity of coronary 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
Time frame: Through inclusion completion, expected after 18 months of enrolment
Positive predictive value of coronary 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
Time frame: Through inclusion completion, expected after 18 months of enrolment
Safety endpoint
Time frame: Through inclusion completion, expected after 18 months of enrolment
Feasibility of an FFR-CT strategy in case of high-risk ACS, defined as the number of cases among enrolled patients where CT and FFR-CT is not feasible (moving artefacts, quality…)
Time frame: Through inclusion completion, expected after 18 months of enrolment
Accuracy, of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Sensitivity of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Specificity of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Negative predictive value of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Positive predictive value of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Accuracy of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Sensitivity of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Specificity of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Negative predictive value of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Positive predictive value of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to invasive FFR in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to FFRangio™ in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to FFR-CT in high-risk ACS patients
Time frame: Through inclusion completion, expected after 18 months of enrolment
Natural history of deferred lesions according to invasive FFR in term of major adverse cardiac events (MACE)
Time frame: Through follow-up completion, expected 30 months after study initiation
Natural history of deferred lesions according to FFR-CT, in term of major adverse cardiac events (MACE)
Time frame: Through follow-up completion, expected 30 months after study initiation
Natural history of deferred lesions according to CT in term of major adverse cardiac events (MACE)
Time frame: Through follow-up completion, expected 30 months after study initiation
Natural history of deferred lesions according to FFRangio™ in term of major adverse cardiac events (MACE)
Time frame: Through follow-up completion, expected 30 months after study initiation
Results and safety
The study was stopped early (reason given: Slow enrolment during the COVID pandemics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane Fournier, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrolment during the COVID pandemics). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Through inclusion completion, expected after 18 months of enrolment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.