Coronary Artery DiseaseiFRCTNCT01747031
Determination of Instantaneous Wave-Free Ratio by Computed Tomography
A study testing PressureWire™ Certus(St. Jude Medical Systems, Sweden) in people with Coronary Artery Disease, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The iFRCT study is a prospective, multicenter study to evaluate the diagnostic performance of iFRCT with the use of ≥64-detector row CT scanners for the detection and exclusion of significant obstructive coronary artery disease, defined by invasive fractiona flow reserve (FFR) as the reference standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PressureWire™ Certus(St. Jude Medical Systems, Sweden)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter
- Undergoing clinically indicated invasive coronary angiography with FFR
Who cannot join
- A history of CABG surgery
- Prior percutaneous coronary intervention with suspected instent restenosis
- Suspicion of or recent acute coronary syndrome
- Complex congenital heart disease
- Prior pacemaker or defibrillator
- Prosthetic heart valve
Show all 18Show fewer
- Significant arrhythmia
- heart rate >100 beats/min
- systolic blood pressure≤90 mmHg
- contraindication to beta blockers, nitroglycerin or adenosine
- Serum creatinine level greater than 1.5 mg per dL
- Allergy to iodinated contrast
- Pregnant state
- Body mass index greater than 35
- Evidence of active clinical instability or lifethreatening disease
- Canadian Cardiovascular Society class IV angina
- nonevaluable CCTA as determined by the CCTA core laboratory
- Inability to adhere to study procedures
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, 200072
About this study
Official title: Diagnostic Performance of Instantaneous Wave-Free Ratio From Computed Tomography
The iFRCT study is a prospective, multicenter study to evaluate the diagnostic performance of iFRCT with the use of ≥64-detector row CT scanners for the detection and exclusion of significant obstructive coronary artery disease, defined by invasive fractiona flow reserve (FFR) as the reference standard.
Read the detailed description
Noninvasive fractional flow reserve (FFR) computed from CT (FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), and several clinical trials have revealed that the FFRCT has a good correlation with invasive FFR, also use of noninvasive FFRCT plus Computed Tomography (CT ) among stable patients with suspected or known CAD was associated with improved diagnostic accuracy and discrimination vs CT alone for the diagnosis of hemodynamically significant CAD.
The cornerstone of FFR is the linear relationship between pressure and flow under conditions of constant (and minimized) intracoronary resistance, so is FFRCT. Under such conditions, pressure and flow are assumed to be directly proportional, and a decrease in pressure across a stenosis reflects a decrease in blood flow to the dependent myocardium. However, even after administration of potent pharmacologic agents such as adenosine, intracoronary resistance is not static, but instead fluctuates in a phasic pattern throughout the cardiac cycle. In addition, for patients who are allergic to pharmacologic agents or with sever lesions which response little to pharmacologic agents, the measurement of FFR is challenging and the lesion are always underestimated. The ADVISE trial revealed that intracoronary resistance is naturally constant and minimized during the wave-free period. The instantaneous wave-free ratio calculated over this period produces a drug-free index of stenosis severity comparable to FFR. But whether iFR calculated from Computed Tomography(iFRCT) is comparable to FFRCT or FFR, and its diagnostic performance remains unknown. Thus the investigators conduct this trial to assess the diagnostic performance of Instantaneous Wave-Free Ratio for diagnosis of hemodynamically significant coronary stenosis.
Instantaneous Wave-Free Ratio calculated from reconstructed heart model.Wave-intensity analysis identified a wave-free period in which intracoronary resistance at rest is similar in variability and magnitude.The investigators define the resting distal-to-proximal pressure ratio during this period as the instantaneous wave-free ratio (iFR).
- Conditions
- Coronary Artery Disease
- Being tested
- PressureWire™ Certus(St. Jude Medical Systems, Sweden)
- Keywords
- iFR, FFR, instantaneous wave-free ratio, fractional flow reserve
- 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.
PressureWire™ Certus(St. Jude Medical Systems, Sweden)Device
Fractional flow reserve measured during cardiac catheterization--A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden) will be advanced past the stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | Single arm study.The investigators will conducte computed tomography,angiography and FFR measurement during angiography in this single arm. Receives: Device: PressureWire™ Certus(St. Jude Medical Systems, Sweden) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of iFRCT
Diagnostic accuracy[Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)]* of CCTA plus iFRCT(instantaneous wave-free ratio calculated in reconstructed heart model) or iFRCT alone to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis at the subject level using binary outcomes when compared to FFR as the reference standard.*Sensitivity measures the proportion of actual positives which are correctly identified. Specificity measures the proportion of negatives which are correctly identified;PPV, or precision rate is the proportion of positive test results that are true positives (such as correct diagnoses);NPV is defined as the proportion of subjects with a negative test result who are correctly diagnosed.
Measured: 1 day
Secondary outcomes (5)
Diagnostic accuracy of iFRCT at the subject level
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus iFRCT or iFRCT alone at the subject level using binary outcomes when compared to FFR as the reference standard.
Measured: 1 day
Diagnostic accuracy of iFRCT at the vessel level
Sensitivity, specificity, PPV and NPV of CCTA plus iFRCT or iFRCT alone for the presence or absence of HD-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.
Measured: 1 day
FFR Numerical Correlation
Per-vessel correlation of the iFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.
Measured: 1 day
FFRCT Numerical Correlation
Per-vessel correlation of the iFRCT numerical value alone with the FFRCT numerical value calculated from the computed tomography.
Measured: 1 day
Predicted Post-PCI FFR Measurement
Diagnostic accuracy of predicted post-percutaneous intervention (PCI) iFRCT alone to determine success or failure of PCI* using binary outcomes when compared to post-PCI FFR at the subject and vessel level using PCI as the reference standard.*PCI success will be defined as post-PCI FFR>0.80, while PCI failure will be defined as post-PCI FFR≤0.80 during adenosine-mediated hyperemia.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014 (estimated)
- Study completionAug 2014 (estimated)
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Ya-Wei Xu, MD, FACC, Principal investigator, Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747031
- Sponsor's protocol ID
- NCT20121204
- Acronym
- iFRCT
- Status last verified
- Dec 2012
- First submitted
- 4 Dec 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.
PubMed 22154731
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Instantaneous Wave-Free Ratio From Computed Tomography
- ClinicalTrials.gov ID
- NCT01747031
- Acronym / sponsor ID
- iFRCT / NCT20121204
- Conditions
- Coronary Artery Disease
- Keywords
- iFR, FFR, instantaneous wave-free ratio, fractional flow reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- 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.
The iFRCT study is a prospective, multicenter study to evaluate the diagnostic performance of iFRCT with the use of ≥64-detector row CT scanners for the detection and exclusion of significant obstructive coronary artery disease, defined by invasive fractiona flow reserve (FFR) as the reference standard.
Detailed description
Noninvasive fractional flow reserve (FFR) computed from CT (FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), and several clinical trials have revealed that the FFRCT has a good correlation with invasive FFR, also use of noninvasive FFRCT plus Computed Tomography (CT ) among stable patients with suspected or known CAD was associated with improved diagnostic accuracy and discrimination vs CT alone for the diagnosis of hemodynamically significant CAD.
The cornerstone of FFR is the linear relationship between pressure and flow under conditions of constant (and minimized) intracoronary resistance, so is FFRCT. Under such conditions, pressure and flow are assumed to be directly proportional, and a decrease in pressure across a stenosis reflects a decrease in blood flow to the dependent myocardium. However, even after administration of potent pharmacologic agents such as adenosine, intracoronary resistance is not static, but instead fluctuates in a phasic pattern throughout the cardiac cycle. In addition, for patients who are allergic to pharmacologic agents or with sever lesions which response little to pharmacologic agents, the measurement of FFR is challenging and the lesion are always underestimated. The ADVISE trial revealed that intracoronary resistance is naturally constant and minimized during the wave-free period. The instantaneous wave-free ratio calculated over this period produces a drug-free index of stenosis severity comparable to FFR. But whether iFR calculated from Computed Tomography(iFRCT) is comparable to FFRCT or FFR, and its diagnostic performance remains unknown. Thus the investigators conduct this trial to assess the diagnostic performance of Instantaneous Wave-Free Ratio for diagnosis of hemodynamically significant coronary stenosis.
Instantaneous Wave-Free Ratio calculated from reconstructed heart model.Wave-intensity analysis identified a wave-free period in which intracoronary resistance at rest is similar in variability and magnitude.The investigators define the resting distal-to-proximal pressure ratio during this period as the instantaneous wave-free ratio (iFR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Device: PressureWire™ Certus(St. Jude Medical Systems, Sweden)Single arm study.The investigators will conducte computed tomography,angiography and FFR measurement during angiography in this single arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter
- Undergoing clinically indicated invasive coronary angiography with FFR
Key exclusion criteria (18 listed)
- A history of CABG surgery
- Prior percutaneous coronary intervention with suspected instent restenosis
- Suspicion of or recent acute coronary syndrome
- Complex congenital heart disease
- Prior pacemaker or defibrillator
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 |
|---|---|---|
| PressureWire™ Certus(St. Jude Medical Systems, Sweden)Fractional flow reserve measured during cardiac catheterization--A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden) will be advanced past the stenosis. | Device | Single arm study |
Primary outcome
Diagnostic Accuracy of iFRCT
Time frame: 1 day
Diagnostic accuracy[Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)]* of CCTA plus iFRCT(instantaneous wave-free ratio calculated in reconstructed heart model) or iFRCT alone to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis at the subject level using binary outcomes when compared to FFR as the reference standard.*Sensitivity measures the proportion of actual positives which are correctly identified. Specificity measures the proportion of negatives which are correctly identified;PPV, or precision rate is the proportion of positive test results that are true positives (such as correct diagnoses);NPV is defined as the proportion of subjects with a negative test result who are correctly diagnosed.
5 secondary outcomes
Diagnostic accuracy of iFRCT at the subject level
Time frame: 1 day
Diagnostic accuracy of iFRCT at the vessel level
Time frame: 1 day
FFR Numerical Correlation
Time frame: 1 day
FFRCT Numerical Correlation
Time frame: 1 day
Predicted Post-PCI FFR Measurement
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Background: PubMed 22154731Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.
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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.
Ya-Wei Xu, MD, FACC principal investigator
Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PressureWire™ Certus(St. Jude Medical Systems, Sweden) in people with Coronary Artery Disease, run by Shanghai 10th People's Hospital at 1 site in China.
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 2 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 11 Dec 2012. 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 China. 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?
Results are not available in the source record.
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 iFRCT (time frame: 1 day). 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 NCT01747031, 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 11 Dec 2012.