Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease
NCT ID: NCT02748603
Last Updated: 2016-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2014-10-31
2016-07-31
Brief Summary
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At least 400 patients will be retrospectively selected among 22 Catheterization Laboratories in Italy in the region of Lombardia and Veneto.
This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and all applicable regulatory requirements.
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Detailed Description
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European Society of Cardiology Guide give precise indications (but often ignored) on the use of PCI or coronary artery bypass grafting according to the extent of coronary artery disease and the site of injury . However, especially in patients with NSTE-ACS often we limit ourselves to dilate the culprit stenosis, leaving untreated other injuries that underlie large myocardial territory, that is, by configuring an incomplete revascularization framework. The calculation of the SYNTAX score residual (that is, what remains after percutaneous revascularization procedure) allows to objectively verify the incompleteness of PCI treatment, which correlates with the outcome in the patient's distance . Moreover, in case of equivocal stenosis, especially in patients with stable coronary disease, large should be the use of a functional assessment using the calculation of the Fractional Flow Reserve (FFR).
This could indicate that the increase of the number of invasive diagnostic tests does not increase the number of patients with coronary artery disease extended, in which is usually indicated a surgical revascularization. So to identify patients at higher risk, may be enough specific investigations and conducted selectively.
The purpose of the pilot study APACHE is to assess the appropriateness of indication and appropriateness of execution of a sample carried out PCI in patients with stable coronary artery disease and in patients with NSTE-ACS (in the ratio 4: 1). As such, the APACHE be considered a quality improvement initiative.
Retrospective observational study, multicenter. The study population will consist of 20 cases of PCI per center (then about 400 PCI in total) selected randomly within the center of the case studies in the previous approval of the study. Of these 16 will be patients with stable coronary artery disease (including 8 with diabetes mellitus in medical therapy) and 4 will be patients with NSTE-ACS (4: 1 ratio).
Patients with a history of coronary artery bypass are excluded. The series will consist of patients in whom the procedure was carried out in the previous year to a declaration of participation in the survey and in any case after the publication of the document. There have been no previous analysis of this type in Italy and is therefore not known what is the rate of inappropriateness for PCI procedures in stable patients. It is not possible therefore to perform a calculation of sample size. However, the investigators believes that for a pilot analysis, an initial sample of 400 PCI procedures, analytically considered, is sufficient to verify the magnitude of the problem in the Italian Catheterization Laboratories.
The investigators anticipate the participation of about 20 centers in total between Lombardia and Veneto italian regions. The study will have an approximate duration of about 2 years.
The data to be collected will be different in patients with nSTE - ACS compared to patients with stable coronary artery disease. As an initiative of quality improvement, and according to extensive international literature on the subject, will not be requested individual informed consent to selected patients but only the approval of the Ethics Committee of the Center Coordinator. Patient data will be de-identified and used only in the aggregate and all individual sensitive information (name, phone, address) will be erased.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patient with non ST Elevation - Acute Coronary Syndrome
No interventions assigned to this group
Patient with stable Coronary Artery Disease (CAD)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Stable Coronary Artery Disease(CAD)
* Unstable Angina or NSTEMI
Exclusion Criteria
* previous CABG
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Italian Society of Invasive Cardiology
OTHER
Responsible Party
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Principal Investigators
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Stefano De Servi, MD
Role: STUDY_CHAIR
Fondazione IRCCS Policlinico San Matteo di Pavia
Sergio Leonardi, MD
Role: STUDY_DIRECTOR
IRCCS Policlinico S. Matteo / CCRC - Cardiovascular Clinical Research Center
Locations
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IRCCS Policlinico S. Matteo
Pavia, Pv, Italy
Countries
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Central Contacts
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References
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Lucas FL, Siewers AE, Malenka DJ, Wennberg DE. Diagnostic-therapeutic cascade revisited: coronary angiography, coronary artery bypass graft surgery, and percutaneous coronary intervention in the modern era. Circulation. 2008 Dec 16;118(25):2797-802. doi: 10.1161/CIRCULATIONAHA.108.789446. Epub 2008 Dec 8.
Bauer T, Mollmann H, Weidinger F, Zeymer U, Seabra-Gomes R, Eberli F, Serruys P, Vahanian A, Silber S, Wijns W, Hochadel M, Nef HM, Hamm CW, Marco J, Gitt AK. Predictors of hospital mortality in the elderly undergoing percutaneous coronary intervention for acute coronary syndromes and stable angina. Int J Cardiol. 2011 Sep 1;151(2):164-9. doi: 10.1016/j.ijcard.2010.05.006. Epub 2010 Jun 3.
Genereux P, Palmerini T, Caixeta A, Rosner G, Green P, Dressler O, Xu K, Parise H, Mehran R, Serruys PW, Stone GW. Quantification and impact of untreated coronary artery disease after percutaneous coronary intervention: the residual SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) score. J Am Coll Cardiol. 2012 Jun 12;59(24):2165-74. doi: 10.1016/j.jacc.2012.03.010. Epub 2012 Apr 4.
Coronary Revascularization Writing Group; Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA; Technical Panel; Masoudi FA, Dehmer GJ, Patel MR, Smith PK, Chambers CE, Ferguson TB Jr, Garcia MJ, Grover FL, Holmes DR Jr, Klein LW, Limacher MC, Mack MJ, Malenka DJ, Park MH, Ragosta M 3rd, Ritchie JL, Rose GA, Rosenberg AB, Russo AM, Shemin RJ, Weintraub WS; Appropriate Use Criteria Task Force; Wolk MJ, Bailey SR, Douglas PS, Hendel RC, Kramer CM, Min JK, Patel MR, Shaw L, Stainback RF, Allen JM; American College of Cardiology Foundation; American College of Cardiology Foundation Appropriate Use Criteria Task Force; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Thoracic Surgery; American Heart Association; American Society of Nuclear Cardiology; Society of Cardiovascular Computed Tomography. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography. J Thorac Cardiovasc Surg. 2012 Apr;143(4):780-803. doi: 10.1016/j.jtcvs.2012.01.061.
Miller FG, Emanuel EJ. Quality-improvement research and informed consent. N Engl J Med. 2008 Feb 21;358(8):765-7. doi: 10.1056/NEJMp0800136. No abstract available.
Dauerman HL. Reasonable incomplete revascularization. Circulation. 2011 May 31;123(21):2337-40. doi: 10.1161/CIRCULATIONAHA.111.033126. Epub 2011 May 16. No abstract available.
Leonardi S, Marino M, Crimi G, Maiorana F, Rizzotti D, Lettieri C, Bettari L, Zuccari M, Sganzerla P, Tresoldi S, Adamo M, Ghiringhelli S, Sponzilli C, Pasquetto G, Pavei A, Pedon L, Bassan L, Bollati M, Camisasca P, Trabattoni D, Brancati M, Poli A, Panciroli C, Lettino M, Tarelli G, Tarantini G, De Luca L, Varbella F, Musumeci G, De Servi S. APpropriAteness of percutaneous Coronary interventions in patients with ischaemic HEart disease in Italy: the APACHE pilot study. BMJ Open. 2017 Sep 5;7(9):e016909. doi: 10.1136/bmjopen-2017-016909.
Study Documents
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Document Type: Report on National Journal
De Servi S, Klugmann S: Qualità e appropriatezza dell'angioplastica coronarica in Lombardia: qualche riflessione sui dati di attivita' del registro della Società Italiana di Cardiologia Invasiva SICI-GISE) . G. Ital Cardiol 2012; 13: 47-9
View DocumentOther Identifiers
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20140003325
Identifier Type: -
Identifier Source: org_study_id
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