Ischemic Heart DiseaseDSE-vs-FFRNCT03383718
DSE vs. FFR in SCAD and BYSTANDER Lesions
An observational study of Ischemic Heart Disease, run by Bajcsy-Zsilinszky Hospital.
Trial summary
Enrollment: Patients with stable coronary artery disease (SCAD) and moderate coronary artery stenoses (30-70 %) Patients with acute myocardial infarction and moderate stenosis of non-culprit arteries (NCL; BYSTANDER LESION) Aims: To assess the diagnostic accuracy of dobutamine stress echocardiography (DSE) and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Revascularisation and Optimal Medical Treatment/OMT
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 1 Dec 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, the suitable patients have at least one moderate coronary artery stenosis identified by coronary angiography. There will be patients with stable coronary artery disease and patients with acute myocardial infarction having at least one non-culprit vessel stenoses.
Who may be able to join
- Age>18 years
- Moderate Coronary Stenosis (30-70 %)
- Stable coronary artery disease or patients with acute myocardial infarction and at least one moderate non-culprit vessel stenosis
Who cannot join
- Left Main Coronary artery stenosis
- Age>80 years
- Known non-cardiovascular disease with poor prognosis
- Patients for whom coronary angiography or stress echocardiography is contraindicated per institutional standard of care (e.g. History of severe and/or anaphylactic contrast reaction)
- Inability to provide informed consent;
- Inability to cooperate with the investigation
- Pregnancy
About this study
Official title: Comparison of Dobutamine Stress Echocardiography and Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease: Stable and Non-culprit Lesions Investigation
Enrollment:
- Patients with stable coronary artery disease (SCAD) and moderate coronary artery stenoses (30-70 %)
- Patients with acute myocardial infarction and moderate stenosis of non-culprit arteries (NCL; BYSTANDER LESION)
Read more
Aims:
- To assess the diagnostic accuracy of dobutamine stress echocardiography (DSE) and invasive fractional flow reserve (FFR) measurement
- To assess the prognostic impact of reclassification by a mismatching negative test
Hypothesis:
- DSE and FFR have similar prognostic value in both clinical settings (SCAD and NCL)
- Considering the strong negative predictive value of both DSE and FFR, one negative test is sufficiently enough to defer revascularisation, even in the case of mismatch
Read the detailed description
Easy accessibility made fractional flow reserve (FFR) a widely accepted method to evaluate myocardial ischaemia in patients with moderate coronary artery stenosis, although the prognostic value for "hard" endpoints such as myocardial infarction and cardiovascular death is equivocal.
Dobutamine stress echocardiography (DSE) is a useful and safe non-invasive functional test for myocardial ichaemia evaluation. There are robust data confirming the prognostic value of DSE regarding the same "hard" endpoints.
In patients with SCAD there are clear recommendations in the recent guidelines both for DSE guided or FFR guided revascularization but the data about prognosis is limited, especially in the case of FFR guidance. The outcome is also equivocal if there is a difference between the invasive and non-invasive test result.
In patients with acute myocardial infarction, more than 50% of patients have multivessel disease. There are clear recommendations for the management of infarct related artery, however controversy still exists for the management of angiographically moderate NCLs.
In DSE vs. FFR prospective trial, the Investigators plan to perform both the DSE and FFR tests in the above mentioned clinical settings, to investigate the correlation between them. The causes of differences between them would be investigated as well as the prognostic impact of reclassification by a second test (either DSE or FFR).
If both tests are positive, revascularisation is planned to be performed (PCI Group). In cases of either double negative or mismatching tests, optimal medical therapy will be chosen (OMT Group) with clinical follow up of at least 2 years.
- Conditions
- Ischemic Heart Disease
- Being tested
- Revascularisation, Optimal Medical Treatment/OMT
- Keywords
- Coronary Artery Disease, Fractional Flow Reserve, Dobutamine Stress Echocardiography, Stable Coronary Artery Disease, Bystander Coronary Artery Disease, Non-Culprit Lesions, Acute Myocardial Infarction
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularisationProcedure or surgery
Also called PCI or CABG
Percutaneous coronary intervention or coronary artery bypass surgery
Optimal Medical Treatment/OMTOther
Standard of care in stable coronary artery disease or after acute myocardial infarction.
| Study group | Role | What they receive |
|---|---|---|
| DSE+/FFR+ | Patients with positive Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve Revascularisation Receives: Procedure: Revascularisation | |
| DSE+/FFR- or DSE-/FFR+ or DSE-/FFR- | Patients with positive Dobutamine Stress Echocardiography and with negative Fractional Flow Reserve
Patients with negative Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve
Patients with negative Dobutamine Stress Echocardiography and with negative Fractional Flow Reserve
Optimal Medical Treatment/OMT Receives: Other: Optimal Medical Treatment/OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Myocardial Infarction
Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischaemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Identification of an intracoronary thrombus by angiography or autopsy
Measured: From baseline to at least 2 years
Target Vessel Revascularisation
The Investigated Vessel need Revascularisation because of at least Canadian Cardiology Society Angina Class III
Measured: From baseline to at least 2 years
Cardiovascular Death
Death occurs due to Cardiovascular cause
Measured: From baseline to at least 2 years
Secondary outcomes (4)
Angina
Rehospitalisation due to Angina
Measured: From baseline to at least 2 years
Heart failure
Rehospitalisation due to Heart Failure
Measured: From baseline to at least 2 years
Non-Cardiac Death
Death occurs due to Non-Cardiovascular cause
Measured: From baseline to at least 2 years
Non-Target Vessel Revascularisation
The Non-Investigated Vessel need Revascularisation
Measured: From baseline to at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Dec 2014
- Primary completion1 Dec 2017
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bajcsy-Zsilinszky Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University Heart and Vascular Center
- Responsible party
- Principal investigator, Peter Andrassy MD.PhD., Bajcsy-Zsilinszky Hospital
- Investigators
- Péter Andrássy, MD.PhD., Principal investigator, Bajcsy-Zsilinszky Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383718
- Sponsor's protocol ID
- 1.0
- Acronym
- DSE-vs-FFR
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2017
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be shared ONLY with the patient's other physicians.
Publications
De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
PubMed 22924638Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
PubMed 19144937Christou MA, Siontis GC, Katritsis DG, Ioannidis JP. Meta-analysis of fractional flow reserve versus quantitative coronary angiography and noninvasive imaging for evaluation of myocardial ischemia. Am J Cardiol. 2007 Feb 15;99(4):450-6. doi: 10.1016/j.amjcard.2006.09.092. Epub 2006 Dec 20.
PubMed 17293182Gaibazzi N, Rigo F, Lorenzoni V, Molinaro S, Bartolomucci F, Reverberi C, Marwick TH. Comparative prediction of cardiac events by wall motion, wall motion plus coronary flow reserve, or myocardial perfusion analysis: a multicenter study of contrast stress echocardiography. JACC Cardiovasc Imaging. 2013 Jan;6(1):1-12. doi: 10.1016/j.jcmg.2012.08.009. Epub 2012 Dec 5.
PubMed 23219414Pattanshetty DJ, Bhat PK, Gandhi S, Pillai DP, Aneja A. Comparing stress testing and fractional flow reserve to evaluate presence, location and extent of ischemia in coronary artery disease. Indian Heart J. 2015 Jan-Feb;67(1):50-5. doi: 10.1016/j.ihj.2015.02.010. Epub 2015 Feb 25.
PubMed 25820051Cortigiani L, Rigo F, Gherardi S, Bovenzi F, Molinaro S, Picano E, Sicari R. Coronary flow reserve during dipyridamole stress echocardiography predicts mortality. JACC Cardiovasc Imaging. 2012 Nov;5(11):1079-85. doi: 10.1016/j.jcmg.2012.08.007.
PubMed 23153906Ojaghi-Haghighi Z, Abtahi F, Fazlolah S, Moladoust H, Maleki M, Gholami S. Coronary flow reserve, strain and strain rate imaging during pharmacological stress before and after percutaneous coronary intervention: comparison and correlation. Echocardiography. 2011 May;28(5):570-4. doi: 10.1111/j.1540-8175.2011.01366.x. Epub 2011 May 4.
PubMed 21539600Dagdelen S, Yuce M, Emiroglu Y, Ergelen M, Pala S, Tanalp AC, Izgi A, Kirma C. Correlation between the tissue Doppler, strain rate, strain imaging during the dobutamine infusion and coronary fractional flow reserve during catheterization: a comparative study. Int J Cardiol. 2005 Jun 22;102(1):127-36. doi: 10.1016/j.ijcard.2004.05.012.
PubMed 15939109Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002179. doi: 10.1161/CIRCIMAGING.114.002179.
PubMed 25711274Takx RA, Blomberg BA, El Aidi H, Habets J, de Jong PA, Nagel E, Hoffmann U, Leiner T. Diagnostic accuracy of stress myocardial perfusion imaging compared to invasive coronary angiography with fractional flow reserve meta-analysis. Circ Cardiovasc Imaging. 2015 Jan;8(1):e002666. doi: 10.1161/CIRCIMAGING.114.002666.
PubMed 25596143van der Sijde JN, Boiten HJ, van Domburg RT, Schinkel AF. Long-Term (>10 Years) Prognostic Value of Dobutamine Stress Echocardiography in a High-Risk Cohort. Am J Cardiol. 2016 Apr 1;117(7):1078-83. doi: 10.1016/j.amjcard.2016.01.002. Epub 2016 Jan 14.
PubMed 26839054Harb SC, Marwick TH. Prognostic value of stress imaging after revascularization: a systematic review of stress echocardiography and stress nuclear imaging. Am Heart J. 2014 Jan;167(1):77-85. doi: 10.1016/j.ahj.2013.07.035. Epub 2013 Nov 21.
PubMed 24332145Cortigiani L, Bigi R, Sicari R, Landi P, Bovenzi F, Picano E. Prognostic value of pharmacological stress echocardiography in diabetic and nondiabetic patients with known or suspected coronary artery disease. J Am Coll Cardiol. 2006 Feb 7;47(3):605-10. doi: 10.1016/j.jacc.2005.09.035. Epub 2006 Jan 18.
PubMed 16458144Jung PH, Rieber J, Stork S, Hoyer C, Erhardt I, Nowotny A, Voelker W, Weidemann F, Ertl G, Klauss V, Angermann CE. Effect of contrast application on interpretability and diagnostic value of dobutamine stress echocardiography in patients with intermediate coronary lesions: comparison with myocardial fractional flow reserve. Eur Heart J. 2008 Oct;29(20):2536-43. doi: 10.1093/eurheartj/ehn204. Epub 2008 May 21.
PubMed 18499651Weidemann F, Jung P, Hoyer C, Broscheit J, Voelker W, Ertl G, Stork S, Angermann CE, Strotmann JM. Assessment of the contractile reserve in patients with intermediate coronary lesions: a strain rate imaging study validated by invasive myocardial fractional flow reserve. Eur Heart J. 2007 Jun;28(12):1425-32. doi: 10.1093/eurheartj/ehm082. Epub 2007 May 15.
PubMed 17504804
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dobutamine Stress Echocardiography and Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease: Stable and Non-culprit Lesions Investigation
- ClinicalTrials.gov ID
- NCT03383718
- Acronym / sponsor ID
- DSE-vs-FFR / 1.0
- Conditions
- Ischemic Heart Disease
- Keywords
- Coronary Artery Disease, Fractional Flow Reserve, Dobutamine Stress Echocardiography, Stable Coronary Artery Disease, Bystander Coronary Artery Disease, Non-Culprit Lesions, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bajcsy-Zsilinszky HospitalUniversity, hospital or other
- Collaborators
- Semmelweis University Heart and Vascular Center
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 26 Dec 2017 (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.
Enrollment:
- Patients with stable coronary artery disease (SCAD) and moderate coronary artery stenoses (30-70 %)
- Patients with acute myocardial infarction and moderate stenosis of non-culprit arteries (NCL; BYSTANDER LESION)
Aims:
- To assess the diagnostic accuracy of dobutamine stress echocardiography (DSE) and invasive fractional flow reserve (FFR) measurement
- To assess the prognostic impact of reclassification by a mismatching negative test
Hypothesis:
- DSE and FFR have similar prognostic value in both clinical settings (SCAD and NCL)
- Considering the strong negative predictive value of both DSE and FFR, one negative test is sufficiently enough to defer revascularisation, even in the case of mismatch
Detailed description
Easy accessibility made fractional flow reserve (FFR) a widely accepted method to evaluate myocardial ischaemia in patients with moderate coronary artery stenosis, although the prognostic value for "hard" endpoints such as myocardial infarction and cardiovascular death is equivocal.
Dobutamine stress echocardiography (DSE) is a useful and safe non-invasive functional test for myocardial ichaemia evaluation. There are robust data confirming the prognostic value of DSE regarding the same "hard" endpoints.
In patients with SCAD there are clear recommendations in the recent guidelines both for DSE guided or FFR guided revascularization but the data about prognosis is limited, especially in the case of FFR guidance. The outcome is also equivocal if there is a difference between the invasive and non-invasive test result.
In patients with acute myocardial infarction, more than 50% of patients have multivessel disease. There are clear recommendations for the management of infarct related artery, however controversy still exists for the management of angiographically moderate NCLs.
In DSE vs. FFR prospective trial, the Investigators plan to perform both the DSE and FFR tests in the above mentioned clinical settings, to investigate the correlation between them. The causes of differences between them would be investigated as well as the prognostic impact of reclassification by a second test (either DSE or FFR).
If both tests are positive, revascularisation is planned to be performed (PCI Group). In cases of either double negative or mismatching tests, optimal medical therapy will be chosen (OMT Group) with clinical follow up of at least 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSE+/FFR+ | – | Procedure: RevascularisationPatients with positive Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve Revascularisation |
| DSE+/FFR- or DSE-/FFR+ or DSE-/FFR- | – | Other: Optimal Medical Treatment/OMTPatients with positive Dobutamine Stress Echocardiography and with negative Fractional Flow Reserve Patients with negative Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve Patients with negative Dobutamine Stress Echocardiography and with negative Fractional Flow Reserve Optimal Medical Treatment/OMT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, the suitable patients have at least one moderate coronary artery stenosis identified by coronary angiography. There will be patients with stable coronary artery disease and patients with acute myocardial infarction having at least one non-culprit vessel stenoses.
Key inclusion criteria (3 listed)
- Age>18 years
- Moderate Coronary Stenosis (30-70 %)
- Stable coronary artery disease or patients with acute myocardial infarction and at least one moderate non-culprit vessel stenosis
Key exclusion criteria (7 listed)
- Left Main Coronary artery stenosis
- Age>80 years
- Known non-cardiovascular disease with poor prognosis
- Patients for whom coronary angiography or stress echocardiography is contraindicated per institutional standard of care (e.g. History of severe and/or anaphylactic contrast reaction)
- Inability to provide informed consent;
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 |
|---|---|---|
| RevascularisationAlso: PCI or CABGPercutaneous coronary intervention or coronary artery bypass surgery | Procedure or surgery | DSE+/FFR+ |
| Optimal Medical Treatment/OMTStandard of care in stable coronary artery disease or after acute myocardial infarction. | Other | DSE+/FFR- or DSE-/FFR+ or DSE-/FFR- |
Primary outcome
Acute Myocardial Infarction
Time frame: From baseline to at least 2 years
Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischaemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB). Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Identification of an intracoronary thrombus by angiography or autopsy
Target Vessel Revascularisation
Time frame: From baseline to at least 2 years
The Investigated Vessel need Revascularisation because of at least Canadian Cardiology Society Angina Class III
Cardiovascular Death
Time frame: From baseline to at least 2 years
Death occurs due to Cardiovascular cause
4 secondary outcomes
Angina
Time frame: From baseline to at least 2 years
Heart failure
Time frame: From baseline to at least 2 years
Non-Cardiac Death
Time frame: From baseline to at least 2 years
Non-Target Vessel Revascularisation
Time frame: From baseline to at least 2 years
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 2 Jan 2020.
- Background: PubMed 22924638De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
- Background: PubMed 19144937Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
- Background: PubMed 17293182Christou MA, Siontis GC, Katritsis DG, Ioannidis JP. Meta-analysis of fractional flow reserve versus quantitative coronary angiography and noninvasive imaging for evaluation of myocardial ischemia. Am J Cardiol. 2007 Feb 15;99(4):450-6. doi: 10.1016/j.amjcard.2006.09.092. Epub 2006 Dec 20.
- Background: PubMed 23219414Gaibazzi N, Rigo F, Lorenzoni V, Molinaro S, Bartolomucci F, Reverberi C, Marwick TH. Comparative prediction of cardiac events by wall motion, wall motion plus coronary flow reserve, or myocardial perfusion analysis: a multicenter study of contrast stress echocardiography. JACC Cardiovasc Imaging. 2013 Jan;6(1):1-12. doi: 10.1016/j.jcmg.2012.08.009. Epub 2012 Dec 5.
- Background: PubMed 25820051Pattanshetty DJ, Bhat PK, Gandhi S, Pillai DP, Aneja A. Comparing stress testing and fractional flow reserve to evaluate presence, location and extent of ischemia in coronary artery disease. Indian Heart J. 2015 Jan-Feb;67(1):50-5. doi: 10.1016/j.ihj.2015.02.010. Epub 2015 Feb 25.
- Background: PubMed 23153906Cortigiani L, Rigo F, Gherardi S, Bovenzi F, Molinaro S, Picano E, Sicari R. Coronary flow reserve during dipyridamole stress echocardiography predicts mortality. JACC Cardiovasc Imaging. 2012 Nov;5(11):1079-85. doi: 10.1016/j.jcmg.2012.08.007.
- Background: PubMed 21539600Ojaghi-Haghighi Z, Abtahi F, Fazlolah S, Moladoust H, Maleki M, Gholami S. Coronary flow reserve, strain and strain rate imaging during pharmacological stress before and after percutaneous coronary intervention: comparison and correlation. Echocardiography. 2011 May;28(5):570-4. doi: 10.1111/j.1540-8175.2011.01366.x. Epub 2011 May 4.
- Background: PubMed 15939109Dagdelen S, Yuce M, Emiroglu Y, Ergelen M, Pala S, Tanalp AC, Izgi A, Kirma C. Correlation between the tissue Doppler, strain rate, strain imaging during the dobutamine infusion and coronary fractional flow reserve during catheterization: a comparative study. Int J Cardiol. 2005 Jun 22;102(1):127-36. doi: 10.1016/j.ijcard.2004.05.012.
- Background: PubMed 25711274Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002179. doi: 10.1161/CIRCIMAGING.114.002179.
- Background: PubMed 25596143Takx RA, Blomberg BA, El Aidi H, Habets J, de Jong PA, Nagel E, Hoffmann U, Leiner T. Diagnostic accuracy of stress myocardial perfusion imaging compared to invasive coronary angiography with fractional flow reserve meta-analysis. Circ Cardiovasc Imaging. 2015 Jan;8(1):e002666. doi: 10.1161/CIRCIMAGING.114.002666.
- Background: PubMed 26839054van der Sijde JN, Boiten HJ, van Domburg RT, Schinkel AF. Long-Term (>10 Years) Prognostic Value of Dobutamine Stress Echocardiography in a High-Risk Cohort. Am J Cardiol. 2016 Apr 1;117(7):1078-83. doi: 10.1016/j.amjcard.2016.01.002. Epub 2016 Jan 14.
- Background: PubMed 24332145Harb SC, Marwick TH. Prognostic value of stress imaging after revascularization: a systematic review of stress echocardiography and stress nuclear imaging. Am Heart J. 2014 Jan;167(1):77-85. doi: 10.1016/j.ahj.2013.07.035. Epub 2013 Nov 21.
- Individual participant dataSharing planned: No. Results will be shared ONLY with the patient's other physicians.
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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.
Péter Andrássy, MD.PhD. principal investigator
Bajcsy-Zsilinszky Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Bajcsy-Zsilinszky Hospital.
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 7 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Acute Myocardial Infarction (time frame: From baseline to at least 2 years). The study lists 3 primary outcomes in all. 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 NCT03383718, which also lists 22 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 2 Jan 2020.