One-Dimensional Mathematical Model-Based Automated Assessment of Fractional Flow Reserve

NCT03797118 | Completed

• 1 other identifier: 17-51-53160
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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-dimensional mathematical model constructed by means of an automated algorithm. Noninvasive method values are thereafter compared with invasive method values.

Conditions

Coronary Artery Disease

Keywords

noninvasive assessment of the fractional flow reserve; coronary computed tomography angiography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

FFRct

EXPERIMENTAL

Patients will receive cCTA, ICA, FFRct, and FFRinv per protocol.

Device: FFR

Interventions

FFR DEVICE

Fractional flow reserve measured during cardiac catheterization

FFRct

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Daria Gognieva

Moscow, 127540, Russia

Location

Related Publications (1)

• 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.

  PMID: 29921835 BACKGROUND

Related Links

• Am J Case Rep. 2018 Jun 20;19:724-728. doi: 10.12659/AJCR.908449.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Daria Gognieva, MD

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

• Philipp Kopylov, Professor

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2018
• First Posted: January 8, 2019
• Study Start: April 5, 2017
• Primary Completion: June 5, 2019
• Study Completion: July 5, 2019
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)