Coronary Artery Disease Clinical Trial
Official title:
The First Experience With Using a One-dimensional Mathematical Model With Fully Automated Algorithm of Extraction of Patient-specific Geometry From CT Images for a Noninvasive Assessment of Fractional Flow Reserve.
NCT number | NCT03797118 |
Other study ID # | 17-51-53160 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 5, 2017 |
Est. completion date | July 5, 2019 |
Verified date | May 2020 |
Source | I.M. Sechenov First Moscow State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the diagnostic efficiency of an automated method of noninvasive
assessment of the fractional reserve of coronary blood flow.
Fractional flow reserve is estimated with a one-dimensional mathematical model constructed by
means of an automated algorithm. Noninvasive method values are thereafter compared with
invasive method values.
Status | Completed |
Enrollment | 31 |
Est. completion date | July 5, 2019 |
Est. primary completion date | June 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Patients providing written informed consent 2. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA) 3. Has undergone >640 multidetector CCTA within 60 days prior to ICA 4. No cardiac interventional therapy between the CCTA and ICA Exclusion Criteria: 1. Prior coronary artery bypass graft (CABG) surgery 2. Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel 3. Contraindication to adenosine, including 2nd or 3rd-degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, severe COPD or bronchodilator-dependent COPD 4. Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina) 5. Recent prior myocardial infarction within 40 days of ICA 6. Known complex congenital heart disease 7. Prior pacemaker or internal defibrillator lead implantation 8. Prosthetic heart valve 9. Significant arrhythmia or tachycardia 10. Impaired chronic renal function (serum creatinine >1.5 mg/dl 11. Patients with known anaphylactic allergy to iodinated contrast 12. Pregnancy or unknown pregnancy status 13. Body mass index >35 14. Patient requires an emergent procedure 15. Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema 16. Any active, serious, life-threatening disease with a life expectancy of less than 2 months 17. Inability to comply with study procedures |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Daria Gognieva | Moscow |
Lead Sponsor | Collaborator |
---|---|
I.M. Sechenov First Moscow State Medical University |
Russian Federation,
Gognieva D, Gamilov T, Pryamonosov R, Betelin V, Ternovoy SK, Serova NS, Abugov S, Shchekochikhin D, Mitina Y, El-Manaa H, Kopylov P. One-Dimensional Mathematical Model-Based Automated Assessment of Fractional Flow Reserve in a Patient with Silent Myocardial Ischemia. Am J Case Rep. 2018 Jun 20;19:724-728. doi: 10.12659/AJCR.908449. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic Accuracy of FFRct | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FFRct at the vessel level using binary outcomes whith compared to FFR as the reference standard. | through study completion, an average of 8 months |
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