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

NCT04052763 | Terminated FDA Device

• 1 other identifier: no defined yet
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

NSTE-ACS; FFR-CT; FFRangio™

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Through inclusion completion, expected after 18 months of enrolment

Study Arms (1)

High-risk ACS patients

High-risk ACS patients admitted to the emergency departement witch chest pain.

Diagnostic Test: FFR-CT; Diagnostic Test: FFRangio™

Interventions

FFR-CT DIAGNOSTIC_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.

High-risk ACS patients

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.

High-risk ACS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

High-risk acute coronary syndrome patients admitted to the emergency departement

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Stephane Fournier, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Resident, Principal Investigator

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 12, 2019
• Study Start: August 28, 2019
• Primary Completion: April 1, 2022
• Study Completion: January 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CH (1)