Fractional Flow Reserve, MyocardialDETECTISCHEMIANCT03420131
Diagnostic Agreement of iFR and QFR.
An observational study of Fractional Flow Reserve, Myocardial and Coronary Artery Disease, run by Contilia Clinical Research Institute at 1 site in Germany.
Trial summary
A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractional Flow Reserve, Myocardial, Coronary Artery Disease
- What is being tested?
- QFR and iFR
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2017to 1 Oct 2018
- Phase
- Observational
- 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
Study population: Patients that undergo angiography because of symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing or abnormal noninvasive testing) and in whom hemodynamic evaluation of an intermediate stenosis is indicated should be screened and considered for participation in the trial The trial design is set up to be representative for the patient population that under current guidelines should be evaluated with FFR. Therefore the exclusion criteria are limited to the contraindications for adenosine and previous CABG which would not allow accurate evaluation by FFR and QFR respectively.
Who may be able to join
- Age > 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
- Patients witch semi recent (>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
- Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- Eligible for coronary angiography and/or percutaneous coronary intervention
- Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
Who cannot join
- Contraindication to adenosine administration
- Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Contilia heart and vascular center
Essen, North Rhine-Westphalia, 45138
Christoph J Jensen, MD, 00492018970 ext. 86222, c.jensen@contilia.de
Pieter Ghijselinck, MD, 00492018970 ext. 86274, p.ghijselinck@contilia.de
About this study
Official title: DETErmining the funCTional Significance of Intermediate Stenoses in isCHEMIc heArt Disease (DETECT ISCHEMIA): Diagnostic Agreement of iFR and QFR.
A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.
Read the detailed description
During coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. It is necessary to evaluate the functional significance to guide their treatment.
Fractional Flow Reserve (FFR) is the current gold standard for determining this functional significance but its adoption in clinical practice remains low. The instantaneous wave-free ratio (iFR) is an alternative way to determine the flow-limiting characteristics of a coronary stenosis with a pressure wire but without the need to induce hyperemia. Large randomised trials have confirmed the non-inferiority of iFR in respect to FFR in terms of outcome.
Quantitative Flow Ratio (QFR) is another new method for evaluating the functional significance of coronary stenosis It is a software-based analysis of conventional angiographic images to estimate the pressure drop caused by a coronary stenosis. The diagnostic agreement with FFR seemed promising in the FAVOR Pilot Study and a larger trial is enrolling for confirmation.
A stepwise approach of QFR and iFR could make the functional assessment of intermediate stenoses more practical and cost-effective. However before being used as a combination in daily practice, QFR has to be validated in respect to iFR.
The primary objective of the trial is to investigate the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting
- Being tested
- QFR and iFR
- Keywords
- instantaneous Flow Ratio, Quantitative Flow 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.
QFR and iFRDiagnostic test
iFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option.
QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland
| Study group | Role | What they receive |
|---|---|---|
| FFR-iFR-QFR group | Not described Receives: Diagnostic Test: QFR and iFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of QFR in comparison to iFR
reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to iFR
Measured: 1 hour
QFR- iFR diagnostic grey zone calculation.
QFR limits for achieving 95% sensitivity and specificity in comparison to iFR
Measured: 1 hour
Secondary outcomes (7)
Diagnostic performance of QFR in comparison to FFR
reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to FFR
Measured: 1 hour
QFR- FFR diagnostic grey zone calculation.
QFR limits for achieving 95% sensitivity and specificity in comparison to FFR
Measured: 1 hour
Diagnostic performance of iFR in comparison to FFR
reported as sensitivity, specificity, positive and negative likelihood ratio of iFR according to FFR
Measured: 1 hour
iFR- FFR diagnostic grey zone calculation.
iFR limits for achieving 95% sensitivity and specificity in comparison to FFR
Measured: 1 hour
effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.
Influence of minimum luminal area (MLA), percentage area stenosis, lesion length, and minimum luminal diameter (MLD) and percentage diameter stenosis in the prediction of QFR-iFR-FFR disagreement.
Measured: 1 hour
Effect of lesion location on QFR-iFR-FFR disagreement.
Evaluation of lesion location in the prediction of QFR-iFR-FFR disagreement.
Measured: 1 hour
Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement.
Evaluation of p20-DAC2 score in proximal and mid-LAD stenosis in in the prediction of QFR-iFR-FFR disagreement.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start18 Jul 2017
- Primary completion28 Jul 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractional Flow Reserve, MyocardialStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Contilia Clinical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Jensen, MD Associate Prof., Contilia Clinical Research Institute
- Investigators
- Christoph j Jensen, MD, Principal investigator, contilia heart and vascular center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420131
- Sponsor's protocol ID
- U1111-1199-4364
- Acronym
- DETECTISCHEMIA
- Status last verified
- Jan 2018
- First submitted
- 27 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DETErmining the funCTional Significance of Intermediate Stenoses in isCHEMIc heArt Disease (DETECT ISCHEMIA): Diagnostic Agreement of iFR and QFR.
- ClinicalTrials.gov ID
- NCT03420131
- Acronym / sponsor ID
- DETECTISCHEMIA / U1111-1199-4364
- Keywords
- instantaneous Flow Ratio, Quantitative Flow Ratio, Fractional Flow Reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Contilia Clinical Research InstituteUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 28 Jul 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 5 Feb 2018 (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.
A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.
Detailed description
During coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. It is necessary to evaluate the functional significance to guide their treatment.
Fractional Flow Reserve (FFR) is the current gold standard for determining this functional significance but its adoption in clinical practice remains low. The instantaneous wave-free ratio (iFR) is an alternative way to determine the flow-limiting characteristics of a coronary stenosis with a pressure wire but without the need to induce hyperemia. Large randomised trials have confirmed the non-inferiority of iFR in respect to FFR in terms of outcome.
Quantitative Flow Ratio (QFR) is another new method for evaluating the functional significance of coronary stenosis It is a software-based analysis of conventional angiographic images to estimate the pressure drop caused by a coronary stenosis. The diagnostic agreement with FFR seemed promising in the FAVOR Pilot Study and a larger trial is enrolling for confirmation.
A stepwise approach of QFR and iFR could make the functional assessment of intermediate stenoses more practical and cost-effective. However before being used as a combination in daily practice, QFR has to be validated in respect to iFR.
The primary objective of the trial is to investigate the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFR-iFR-QFR group | – | Diagnostic Test: QFR and iFR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that undergo angiography because of symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing or abnormal noninvasive testing) and in whom hemodynamic evaluation of an intermediate stenosis is indicated should be screened and considered for participation in the trial The trial design is set up to be representative for the patient population that under current guidelines should be evaluated with FFR. Therefore the exclusion criteria are limited to the contraindications for adenosine and previous CABG which would not allow accurate evaluation by FFR and QFR respectively.
Key inclusion criteria (5 listed)
- Age > 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
- Patients witch semi recent (>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
- Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- Eligible for coronary angiography and/or percutaneous coronary intervention
- Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
Key exclusion criteria (2 listed)
- Contraindication to adenosine administration
- Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
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 |
|---|---|---|
| QFR and iFRiFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland | Diagnostic test | FFR-iFR-QFR group |
Primary outcome
Diagnostic performance of QFR in comparison to iFR
Time frame: 1 hour
reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to iFR
QFR- iFR diagnostic grey zone calculation.
Time frame: 1 hour
QFR limits for achieving 95% sensitivity and specificity in comparison to iFR
7 secondary outcomes
Diagnostic performance of QFR in comparison to FFR
Time frame: 1 hour
QFR- FFR diagnostic grey zone calculation.
Time frame: 1 hour
Diagnostic performance of iFR in comparison to FFR
Time frame: 1 hour
iFR- FFR diagnostic grey zone calculation.
Time frame: 1 hour
effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.
Time frame: 1 hour
Effect of lesion location on QFR-iFR-FFR disagreement.
Time frame: 1 hour
Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement.
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Christoph j Jensen, MD principal investigator
contilia heart and vascular center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractional Flow Reserve, Myocardial and Coronary Artery Disease, run by Contilia Clinical Research Institute at 1 site in Germany.
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 5 inclusion and 2 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 5 Feb 2018. 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 Germany. 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?
Contact Christoph Jensen, MD, PHD (0049-201-897-86222, c.jensen@contilia.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of QFR in comparison to iFR (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2018.