Status:
COMPLETED
One-Dimensional Mathematical Model-Based Automated Assessment of Fractional Flow Reserve
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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-dimen...
Detailed Description
Noninvasive assessment of Fractional Flow Reserve is almost never applied in the Russian Federation due to the relative novelty and study insufficiency, lack of the appropriate resource base, specific...
Eligibility Criteria
Inclusion
- Patients providing written informed consent
- Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)
- Has undergone \>640 multidetector CCTA within 60 days prior to ICA
- No cardiac interventional therapy between the CCTA and ICA
Exclusion
- Prior coronary artery bypass graft (CABG) surgery
- Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel
- 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
- Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
- Recent prior myocardial infarction within 40 days of ICA
- Known complex congenital heart disease
- Prior pacemaker or internal defibrillator lead implantation
- Prosthetic heart valve
- Significant arrhythmia or tachycardia
- Impaired chronic renal function (serum creatinine \>1.5 mg/dl
- Patients with known anaphylactic allergy to iodinated contrast
- Pregnancy or unknown pregnancy status
- Body mass index \>35
- Patient requires an emergent procedure
- 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
- Any active, serious, life-threatening disease with a life expectancy of less than 2 months
- Inability to comply with study procedures
Key Trial Info
Start Date :
April 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03797118
Start Date
April 5 2017
End Date
July 5 2019
Last Update
May 18 2020
Active Locations (1)
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1
Daria Gognieva
Moscow, Russia, 127540