Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease

NCT02748603 | Unknown

• 1 other identifier: 20140003325
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

An observational, retrospective, multicenter, blinded adjudication study to evaluate the clinical appropriateness of Percutaneous Coronary Intervention (PCI) indication and execution in patients with stable Coronary Artery Disease (CAD) and in patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS) (ratio 4:1). Half of the included patients will be diabetic. Also the implementation of selected, key guideline recommendations will be examined. 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.

Conditions

Non ST Elevation Acute Coronary Syndromes; Stable Coronary Syndromes; NSTEMI; Unstable Angina

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with stable Coronary Artery Disease (CAD) whose clinical indication was appropriate for the treatment with Percutaneous Coronary Intervention (PCI).

  Appropriateness will be defined by a final score of ≥ 7 of the Central Heart Team according to appropriate use criteria.

  3 months

Secondary Outcomes (8)

• Proportion of patients with complex lesions (left main, proximal LAD, three-vessel disease) treated ad hoc without documentation of Heart Team discussion in the medical records with stable CAD.

  3 months

• Proportion of patients receiving incomplete revascularization (i.e. residual SYNTAX > 8)Heart Team or in patients without documented ischemia with stable CAD.

  3 months

• Proportion of patients receiving guideline-recommended medical therapy at the time of PCI with stable CAD.

  3 months

• Incidence of FFR-guided PCI for stenosis of uncertain significance according to the Central Heart Team or in patients without documented ischemia with stable CAD.

  3 months

• Proportion of patients who received PCI but with an indication for CABG according to guidelines and no Heart team discussion in the medical record with stable CAD.

  3 months

Study Arms (2)

Patient with non ST Elevation - Acute Coronary Syndrome

Patient with stable Coronary Artery Disease (CAD)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty patients per center will be selected among those who underwent PCI in the last months, going backwards from the date of first Site visit. Selection will be stratified for clinical presentation in two subgroups (stable CAD:NSTEACS = 4:1) and diabetes status (1:1) for each subgroups.

You may qualify if:

• Age \>= 18 yrs
• Stable Coronary Artery Disease(CAD)
• Unstable Angina or NSTEMI

You may not qualify if:

• STEMI at presentation
• previous CABG

Sponsors & Collaborators

• Italian Society of Invasive Cardiology: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

IRCCS Policlinico S. Matteo

Pavia, Pv, 27100, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 19064681 RESULT

• 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.

  PMID: 20605241 RESULT

• 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.

  PMID: 22483327 RESULT

• 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.

  PMID: 22424518 RESULT

• 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.

  PMID: 18287598 RESULT

• 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.

  PMID: 21576647 RESULT

• 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.

  PMID: 28877948 DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Stefano De Servi, MD

  Fondazione IRCCS Policlinico San Matteo di Pavia

  STUDY CHAIR

• Sergio Leonardi, MD

  IRCCS Policlinico S. Matteo / CCRC - Cardiovascular Clinical Research Center

  STUDY DIRECTOR

Central Study Contacts

Florinda Maiorana, DBiotech, PHD

CONTACT

0382982105; f.maiorana@smatteo.pv.it

Diego Rizzotti, DBiotech

CONTACT

0382982105; d.rizzotti@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 22, 2016
• Study Start: October 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

IT (1)