Coronary Artery DiseaseNCT03797118
One-Dimensional Mathematical Model-Based Automated Assessment of Fractional Flow Reserve
A study testing FFR in people with Coronary Artery Disease, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FFR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteRussia
- Study dates
- 5 Apr 2017to 5 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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 necessary software and trained qualified personnel.
In 2015, scientists from the Institute of Numerical Mathematics RAS in collaboration with specialists of the I.M. Sechenov First Moscow State Medical University developed a noninvasive method of fractional flow reserve assessment based on a one-dimensional mathematical model. A model is constructed based on images derived from the coronary computed tomography angiography performed by standard protocol; the method is fully automated.
The aim of our study is to evaluate the diagnostic efficiency of this technique in clinical practice.
This is a pilot study; we are planning to enroll 30 patients: 13 of them underwent 64-slice computed tomography and are included retrospectively; 17 will be included prospectively, with a 640-slice CT scan. Specialists from the Laboratory of Mathematical Modeling will process CT images and evaluate noninvasive FFR. Ischemia is confirmed if FFR < 0.80 and disproved if FFR ≥ 0.80. After that, the prospective group of patients will be hospitalized for invasive FFR assessment as a reference standard; if ischemia is proved, patients will undergo stent implantation. In the retrospective group, patients already have invasive FFR values estimated.
Statistical analysis will be performed using R programming language packages (cran-r.project.com). Continuous variables will be presented as mean values ± standard deviations, order variables will be presented as medians with interquartile ranges in parentheses. We are going to use the D'Agostino-Pearson omnibus test for the assessment of normality of distribution and construct a Q-Q Plot. We will compare these two methods with the Bland-Altman analysis and ROC-analysis and will assess the degree of correlation with the Pearson's chi-squared.
The study should result in determining the sensitivity, specificity, positive and negative predictive values of the method.
After the active phase of the research is done, we are planning to proceed observation on the prospective group of patients to verify the endpoints.
- Conditions
- Coronary Artery Disease
- Being tested
- FFR
- Keywords
- noninvasive assessment of the fractional flow reserve, coronary computed tomography angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFRDevice
Fractional flow reserve measured during cardiac catheterization
| Study group | Role | What they receive |
|---|---|---|
| FFRct | Experimental | Patients will receive cCTA, ICA, FFRct, and FFRinv per protocol. Receives: Device: FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start5 Apr 2017
- Primary completion5 Jun 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daria Gognieva, I.M. Sechenov First Moscow State Medical University
- Investigators
- Daria Gognieva, MD, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)Philipp Kopylov, Professor, Study director, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797118
- Sponsor's protocol ID
- 17-51-53160
- Status last verified
- May 2020
- First submitted
- 22 Dec 2018
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
Publications
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.
PubMed 29921835
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03797118
- Acronym / sponsor ID
- 17-51-53160
- Conditions
- Coronary Artery Disease
- Keywords
- noninvasive assessment of the fractional flow reserve, coronary computed tomography angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 necessary software and trained qualified personnel.
In 2015, scientists from the Institute of Numerical Mathematics RAS in collaboration with specialists of the I.M. Sechenov First Moscow State Medical University developed a noninvasive method of fractional flow reserve assessment based on a one-dimensional mathematical model. A model is constructed based on images derived from the coronary computed tomography angiography performed by standard protocol; the method is fully automated.
The aim of our study is to evaluate the diagnostic efficiency of this technique in clinical practice.
This is a pilot study; we are planning to enroll 30 patients: 13 of them underwent 64-slice computed tomography and are included retrospectively; 17 will be included prospectively, with a 640-slice CT scan. Specialists from the Laboratory of Mathematical Modeling will process CT images and evaluate noninvasive FFR. Ischemia is confirmed if FFR < 0.80 and disproved if FFR ≥ 0.80. After that, the prospective group of patients will be hospitalized for invasive FFR assessment as a reference standard; if ischemia is proved, patients will undergo stent implantation. In the retrospective group, patients already have invasive FFR values estimated.
Statistical analysis will be performed using R programming language packages (cran-r.project.com). Continuous variables will be presented as mean values ± standard deviations, order variables will be presented as medians with interquartile ranges in parentheses. We are going to use the D'Agostino-Pearson omnibus test for the assessment of normality of distribution and construct a Q-Q Plot. We will compare these two methods with the Bland-Altman analysis and ROC-analysis and will assess the degree of correlation with the Pearson's chi-squared.
The study should result in determining the sensitivity, specificity, positive and negative predictive values of the method.
After the active phase of the research is done, we are planning to proceed observation on the prospective group of patients to verify the endpoints.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFRct | Experimental | Device: FFRPatients will receive cCTA, ICA, FFRct, and FFRinv per protocol. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFRFractional flow reserve measured during cardiac catheterization | Device | FFRct |
Primary outcome
Diagnostic Accuracy of FFRct
Time frame: through study completion, an average of 8 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Background: PubMed 29921835Gognieva 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.
- Am J Case Rep. 2018 Jun 20;19:724-728. doi: 10.12659/AJCR.908449.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daria Gognieva, MD principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Philipp Kopylov, Professor study director
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR in people with Coronary Artery Disease, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of FFRct (time frame: through study completion, an average of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.