Coronary Artery DiseaseCONTRASTNCT02184117
CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
An observational study of Coronary Artery Disease, run by The University of Texas Health Science Center, Houston at 11 sites in 9 countries.
Trial summary
The purpose of this study is to determine the diagnostic performances of iodine contrast medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be measured using standard adenosine. 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?
- Adenosine, Contrast Media and Resting conditions
- Type of treatment
- Injection or infusion
- How many people
- 763 participants
- Where
- 11 sitesin 9 countries
- Study dates
- Jul 2014to May 2015
- 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 undergoing FFR assessment for standard clinical indications
Who may be able to join
- Age 18 years or older.
- Undergoing FFR assessment for standard clinical indications.
- Ability to understand and willingness to sign a written informed consent.
Who cannot join
- Prior coronary artery bypass grafting (CABG).
- Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by pressure wire placement.
- Known severe left ventricular hypertrophy (septal wall thickness at echocardiography of >13 mm).
- Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
- Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
- Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included.
- Severe cardiomyopathy (ejection fraction <30%).
- Renal insufficiency such that an additional 12 to 20 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.
Trial locations and contacts
11 sites in 9 countries.
11 sites in 9 countries
United States2 sites
Integris Health
Oklahoma City, Oklahoma, 73112
Stanford University, Palo Alto VA
Palo Alto, California, 94304
South Korea2 sites
Seoul National University College of Medicine
Seoul, 110-744
Asan Medical Center
Seoul, 138-736
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, G81 4HX
About this study
The purpose of this study is to determine the diagnostic performances of iodine contrast medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be measured using standard adenosine. We hypothesize that contrast FFR will offer superior diagnostic agreement compared to resting conditions.
Read the detailed description
We are conducting a diagnostic accuracy study. The reference standard is adenosine-derived FFR. The diagnostic tests undergoing evaluation are resting conditions and hyperemia induced by intracoronary injection of contrast medium. While all these tests give a continuous result, we will apply binary cutoffs for comparison to FFR≤0.8 as the reference standard. Subjects will be selected prospectively from consecutive patients undergoing FFR assessment for standard clinical indications. The paired comparative design means that each patient will undergo resting (baseline), post-contrast, and adenosine-derived measurements. To enhance test integrity, all pressure recordings will be analyzed in a central physiology core laboratory blinded to clinical data and recruiting site.
- Conditions
- Coronary Artery Disease
- Being tested
- Adenosine, Contrast Media, Resting conditions
- Keywords
- Fractional Flow Reserve, Myocardial, Adenosine, Contrast Media
- 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.
AdenosineDrug
Intracoronary or intravenous adenosine to induce hyperemia for reference FFR
Contrast MediaDrug
Intracoronary injection of contrast medium to induce hyperemia for "contrast FFR"
Resting conditionsDrug
Baseline measurement of aortic and coronary pressures
| Study group | Role | What they receive |
|---|---|---|
| All patients | Entire cohort undergoes paired testing Receives: Drug: Adenosine; Drug: Contrast Media; Drug: Resting conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement with binary FFR≤0.80
To quantify any improvement in binary agreement from resting conditions to contrast medium injection, using adenosine-derived FFR≤0.8 as the reference standard.
Measured: Baseline
Secondary outcomes (2)
Binary diagnostic performance
To describe the diagnostic performance of resting conditions and contrast medium injection using sensitivity and specificity, positive and negative predictive value, and area under the receiver operating characteristic (ROC) curve, compared to adenosine-derived FFR≤0.8 as the reference standard.
Measured: Baseline
Continuous relationship with FFR
To determine the relationship between adenosine-derived FFR and either resting conditions or contrast medium injection using scatter plots (correlation coefficient) and Bland-Altman analysis (bias and limits of agreement).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 763 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Nils Johnson, The University of Texas Health Science Center, Houston
- Investigators
- Nils P Johnson, MD, MS, Principal investigator, University of Texas Medical School at HoustonWilliam F Fearon, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184117
- Sponsor's protocol ID
- HSC-MS-14-0399
- Acronym
- CONTRAST
- Status last verified
- May 2016
- First submitted
- 2 Jul 2014
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
De Bruyne B, Pijls NH, Barbato E, Bartunek J, Bech JW, Wijns W, Heyndrickx GR. Intracoronary and intravenous adenosine 5'-triphosphate, adenosine, papaverine, and contrast medium to assess fractional flow reserve in humans. Circulation. 2003 Apr 15;107(14):1877-83. doi: 10.1161/01.CIR.0000061950.24940.88. Epub 2003 Mar 31.
PubMed 12668522Johnson NP, Jeremias A, Zimmermann FM, Adjedj J, Witt N, Hennigan B, Koo BK, Maehara A, Matsumura M, Barbato E, Esposito G, Trimarco B, Rioufol G, Park SJ, Yang HM, Baptista SB, Chrysant GS, Leone AM, Berry C, De Bruyne B, Gould KL, Kirkeeide RL, Oldroyd KG, Pijls NHJ, Fearon WF. Continuum of Vasodilator Stress From Rest to Contrast Medium to Adenosine Hyperemia for Fractional Flow Reserve Assessment. JACC Cardiovasc Interv. 2016 Apr 25;9(8):757-767. doi: 10.1016/j.jcin.2015.12.273.
PubMed 27101902Carson RG. A cogent technique to circumvent the use of (some) ratio measures in physiology. J Physiol. 2024 Oct;602(19):4713-4728. doi: 10.1113/JP285214. Epub 2024 Sep 5.
PubMed 39234878Achim A, Johnson NP, Liblik K, Burckhardt A, Krivoshei L, Leibundgut G. Coronary steal: how many thieves are out there? Eur Heart J. 2023 Aug 7;44(30):2805-2814. doi: 10.1093/eurheartj/ehad327.
PubMed 37264699Johnson NP, Matsuo H, Nakayama M, Eftekhari A, Kakuta T, Tanaka N, Christiansen EH, Kirkeeide RL, Gould KL. Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1904-1913. doi: 10.1016/j.jcin.2021.07.041.
PubMed 34503741Johnson NP, Collet C. Can FFR After Stenting Help Reduce Target Vessel Failure? JACC Cardiovasc Interv. 2021 Sep 13;14(17):1901-1903. doi: 10.1016/j.jcin.2021.08.001. No abstract available.
PubMed 34503740Gould KL, Johnson NP, Roby AE, Nguyen T, Kirkeeide R, Haynie M, Lai D, Zhu H, Patel MB, Smalling R, Arain S, Balan P, Nguyen T, Estrera A, Sdringola S, Madjid M, Nascimbene A, Loyalka P, Kar B, Gregoric I, Safi H, McPherson D. Regional, Artery-Specific Thresholds of Quantitative Myocardial Perfusion by PET Associated with Reduced Myocardial Infarction and Death After Revascularization in Stable Coronary Artery Disease. J Nucl Med. 2019 Mar;60(3):410-417. doi: 10.2967/jnumed.118.211953. Epub 2018 Aug 16.
PubMed 30115688Johnson NP, Kirkeeide RL, Gould KL. Same Lesion, Different Artery, Different FFR!? JACC Cardiovasc Imaging. 2019 Apr;12(4):718-721. doi: 10.1016/j.jcmg.2017.11.029. Epub 2018 Jan 17. No abstract available.
PubMed 29361484Kobayashi Y, Johnson NP, Zimmermann FM, Witt N, Berry C, Jeremias A, Koo BK, Esposito G, Rioufol G, Park SJ, Nishi T, Choi DH, Oldroyd KG, Barbato E, Pijls NHJ, De Bruyne B, Fearon WF; CONTRAST Study Investigators. Agreement of the Resting Distal to Aortic Coronary Pressure With the Instantaneous Wave-Free Ratio. J Am Coll Cardiol. 2017 Oct 24;70(17):2105-2113. doi: 10.1016/j.jacc.2017.08.049.
PubMed 29050557Nishi T, Johnson NP, De Bruyne B, Berry C, Gould KL, Jeremias A, Oldroyd KG, Kobayashi Y, Choi DH, Pijls NHJ, Fearon WF; CONTRAST Study Investigators. Influence of Contrast Media Dose and Osmolality on the Diagnostic Performance of Contrast Fractional Flow Reserve. Circ Cardiovasc Interv. 2017 Oct;10(10):e004985. doi: 10.1161/CIRCINTERVENTIONS.117.004985.
PubMed 29042397Matsumura M, Johnson NP, Fearon WF, Mintz GS, Stone GW, Oldroyd KG, De Bruyne B, Pijls NHJ, Maehara A, Jeremias A. Accuracy of Fractional Flow Reserve Measurements in Clinical Practice: Observations From a Core Laboratory Analysis. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1392-1401. doi: 10.1016/j.jcin.2017.03.031.
PubMed 28728652Gargiulo G, Stabile E, Ferrone M, Barbato E, Zimmermann FM, Adjedj J, Hennigan B, Matsumura M, Johnson NP, Fearon WF, Jeremias A, Trimarco B, Esposito G; CONTRST Study Investigators. Diabetes does not impact the diagnostic performance of contrast-based fractional flow reserve: insights from the CONTRAST study. Cardiovasc Diabetol. 2017 Jan 13;16(1):7. doi: 10.1186/s12933-016-0494-2.
PubMed 28086778Johnson NP, Gould KL, Di Carli MF, Taqueti VR. Invasive FFR and Noninvasive CFR in the Evaluation of Ischemia: What Is the Future? J Am Coll Cardiol. 2016 Jun 14;67(23):2772-2788. doi: 10.1016/j.jacc.2016.03.584.
PubMed 27282899Gould KL, Johnson NP. Coronary Blood Flow After Acute MI: Alternative Truths. JACC Cardiovasc Interv. 2016 Mar 28;9(6):614-7. doi: 10.1016/j.jcin.2016.02.009. No abstract available.
PubMed 27013162Gould KL, Johnson NP. Myocardial Bridges: Lessons in Clinical Coronary Pathophysiology. JACC Cardiovasc Imaging. 2015 Jun;8(6):705-9. doi: 10.1016/j.jcmg.2015.02.013. No abstract available.
PubMed 26068287
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
- ClinicalTrials.gov ID
- NCT02184117
- Acronym / sponsor ID
- CONTRAST / HSC-MS-14-0399
- Conditions
- Coronary Artery Disease
- Keywords
- Fractional Flow Reserve, Myocardial, Adenosine, Contrast Media
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 763 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Jul 2014 (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 purpose of this study is to determine the diagnostic performances of iodine contrast medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be measured using standard adenosine. We hypothesize that contrast FFR will offer superior diagnostic agreement compared to resting conditions.
Detailed description
We are conducting a diagnostic accuracy study. The reference standard is adenosine-derived FFR. The diagnostic tests undergoing evaluation are resting conditions and hyperemia induced by intracoronary injection of contrast medium. While all these tests give a continuous result, we will apply binary cutoffs for comparison to FFR≤0.8 as the reference standard. Subjects will be selected prospectively from consecutive patients undergoing FFR assessment for standard clinical indications. The paired comparative design means that each patient will undergo resting (baseline), post-contrast, and adenosine-derived measurements. To enhance test integrity, all pressure recordings will be analyzed in a central physiology core laboratory blinded to clinical data and recruiting site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Drug: Adenosine, Drug: Contrast Media, Drug: Resting conditionsEntire cohort undergoes paired testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing FFR assessment for standard clinical indications
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Undergoing FFR assessment for standard clinical indications.
- Ability to understand and willingness to sign a written informed consent.
Key exclusion criteria (8 listed)
- Prior coronary artery bypass grafting (CABG).
- Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by pressure wire placement.
- Known severe left ventricular hypertrophy (septal wall thickness at echocardiography of >13 mm).
- Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
- Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
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 |
|---|---|---|
| AdenosineIntracoronary or intravenous adenosine to induce hyperemia for reference FFR | Drug | All patients |
| Contrast MediaIntracoronary injection of contrast medium to induce hyperemia for "contrast FFR" | Drug | All patients |
| Resting conditionsBaseline measurement of aortic and coronary pressures | Drug | All patients |
Primary outcome
Agreement with binary FFR≤0.80
Time frame: Baseline
To quantify any improvement in binary agreement from resting conditions to contrast medium injection, using adenosine-derived FFR≤0.8 as the reference standard.
2 secondary outcomes
Binary diagnostic performance
Time frame: Baseline
Continuous relationship with FFR
Time frame: Baseline
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 16 May 2016.
- Background: PubMed 12668522De Bruyne B, Pijls NH, Barbato E, Bartunek J, Bech JW, Wijns W, Heyndrickx GR. Intracoronary and intravenous adenosine 5'-triphosphate, adenosine, papaverine, and contrast medium to assess fractional flow reserve in humans. Circulation. 2003 Apr 15;107(14):1877-83. doi: 10.1161/01.CIR.0000061950.24940.88. Epub 2003 Mar 31.
- Results publication: PubMed 27101902Johnson NP, Jeremias A, Zimmermann FM, Adjedj J, Witt N, Hennigan B, Koo BK, Maehara A, Matsumura M, Barbato E, Esposito G, Trimarco B, Rioufol G, Park SJ, Yang HM, Baptista SB, Chrysant GS, Leone AM, Berry C, De Bruyne B, Gould KL, Kirkeeide RL, Oldroyd KG, Pijls NHJ, Fearon WF. Continuum of Vasodilator Stress From Rest to Contrast Medium to Adenosine Hyperemia for Fractional Flow Reserve Assessment. JACC Cardiovasc Interv. 2016 Apr 25;9(8):757-767. doi: 10.1016/j.jcin.2015.12.273.
- Derived from this study: PubMed 39234878Carson RG. A cogent technique to circumvent the use of (some) ratio measures in physiology. J Physiol. 2024 Oct;602(19):4713-4728. doi: 10.1113/JP285214. Epub 2024 Sep 5.
- Derived from this study: PubMed 37264699Achim A, Johnson NP, Liblik K, Burckhardt A, Krivoshei L, Leibundgut G. Coronary steal: how many thieves are out there? Eur Heart J. 2023 Aug 7;44(30):2805-2814. doi: 10.1093/eurheartj/ehad327.
- Derived from this study: PubMed 34503741Johnson NP, Matsuo H, Nakayama M, Eftekhari A, Kakuta T, Tanaka N, Christiansen EH, Kirkeeide RL, Gould KL. Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1904-1913. doi: 10.1016/j.jcin.2021.07.041.
- Derived from this study: PubMed 34503740Johnson NP, Collet C. Can FFR After Stenting Help Reduce Target Vessel Failure? JACC Cardiovasc Interv. 2021 Sep 13;14(17):1901-1903. doi: 10.1016/j.jcin.2021.08.001. No abstract available.
- Derived from this study: PubMed 30115688Gould KL, Johnson NP, Roby AE, Nguyen T, Kirkeeide R, Haynie M, Lai D, Zhu H, Patel MB, Smalling R, Arain S, Balan P, Nguyen T, Estrera A, Sdringola S, Madjid M, Nascimbene A, Loyalka P, Kar B, Gregoric I, Safi H, McPherson D. Regional, Artery-Specific Thresholds of Quantitative Myocardial Perfusion by PET Associated with Reduced Myocardial Infarction and Death After Revascularization in Stable Coronary Artery Disease. J Nucl Med. 2019 Mar;60(3):410-417. doi: 10.2967/jnumed.118.211953. Epub 2018 Aug 16.
- Derived from this study: PubMed 29361484Johnson NP, Kirkeeide RL, Gould KL. Same Lesion, Different Artery, Different FFR!? JACC Cardiovasc Imaging. 2019 Apr;12(4):718-721. doi: 10.1016/j.jcmg.2017.11.029. Epub 2018 Jan 17. No abstract available.
- Derived from this study: PubMed 29050557Kobayashi Y, Johnson NP, Zimmermann FM, Witt N, Berry C, Jeremias A, Koo BK, Esposito G, Rioufol G, Park SJ, Nishi T, Choi DH, Oldroyd KG, Barbato E, Pijls NHJ, De Bruyne B, Fearon WF; CONTRAST Study Investigators. Agreement of the Resting Distal to Aortic Coronary Pressure With the Instantaneous Wave-Free Ratio. J Am Coll Cardiol. 2017 Oct 24;70(17):2105-2113. doi: 10.1016/j.jacc.2017.08.049.
- Derived from this study: PubMed 29042397Nishi T, Johnson NP, De Bruyne B, Berry C, Gould KL, Jeremias A, Oldroyd KG, Kobayashi Y, Choi DH, Pijls NHJ, Fearon WF; CONTRAST Study Investigators. Influence of Contrast Media Dose and Osmolality on the Diagnostic Performance of Contrast Fractional Flow Reserve. Circ Cardiovasc Interv. 2017 Oct;10(10):e004985. doi: 10.1161/CIRCINTERVENTIONS.117.004985.
- Derived from this study: PubMed 28728652Matsumura M, Johnson NP, Fearon WF, Mintz GS, Stone GW, Oldroyd KG, De Bruyne B, Pijls NHJ, Maehara A, Jeremias A. Accuracy of Fractional Flow Reserve Measurements in Clinical Practice: Observations From a Core Laboratory Analysis. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1392-1401. doi: 10.1016/j.jcin.2017.03.031.
- Derived from this study: PubMed 28086778Gargiulo G, Stabile E, Ferrone M, Barbato E, Zimmermann FM, Adjedj J, Hennigan B, Matsumura M, Johnson NP, Fearon WF, Jeremias A, Trimarco B, Esposito G; CONTRST Study Investigators. Diabetes does not impact the diagnostic performance of contrast-based fractional flow reserve: insights from the CONTRAST study. Cardiovasc Diabetol. 2017 Jan 13;16(1):7. doi: 10.1186/s12933-016-0494-2.
Related trials for Coronary Artery Disease
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Nils P Johnson, MD, MS principal investigator
University of Texas Medical School at Houston
William F Fearon, MD study director
Stanford University
11 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by The University of Texas Health Science Center, Houston at 11 sites in 9 countries.
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 3 inclusion and 8 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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, South Korea, Belgium, France, Italy and 4 more countries. 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?
Agreement with binary FFR≤0.80 (time frame: Baseline). 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 NCT02184117, which also lists 16 linked publications.
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 16 May 2016; AzTrials last refreshed its copy on 1 Nov 2026.