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Trial record 37 of 176 for:    Recruiting, Not yet recruiting, Available Studies | Chest pain

FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT04052763
Recruitment Status : Not yet recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Stephane Fournier, Centre Hospitalier Universitaire Vaudois

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 stenosis, compared to coronary angiography in high-risk acute coronary syndrome patients.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Diagnostic Test: FFR-CT Diagnostic Test: FFRangio™

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 2022

Group/Cohort Intervention/treatment
High-risk ACS patients
High-risk ACS patients admitted to the emergency departement witch chest pain.
Diagnostic Test: FFR-CT
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.

Diagnostic Test: 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.




Primary Outcome Measures :
  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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through inclusion completion, expected after 18 months of enrolment ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Safety endpoint [ Time Frame: Through inclusion completion, expected after 18 months of enrolment ]
    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)

  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]
  19. 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 ]
  20. 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 ]
  21. 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 ]
  22. 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 ]
  23. 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 ]
  24. 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 ]
  25. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
High-risk acute coronary syndrome patients admitted to the emergency departement
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052763


Contacts
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Contact: Stephane Fournier, MD 0041795568205 stephane.fournier@chuv.ch
Contact: David Meier, MD 0041795566054 david.meier@chuv.ch

Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Stephane Fournier, MD CHUV

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Responsible Party: Dr. Stephane Fournier, Chief Resident, Principal Investigator, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04052763     History of Changes
Other Study ID Numbers: no defined yet
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Dr. Stephane Fournier, Centre Hospitalier Universitaire Vaudois:
NSTE-ACS
FFR-CT
FFRangio™
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases