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Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease (APACHE)

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ClinicalTrials.gov Identifier: NCT02748603
Recruitment Status : Unknown
Verified April 2016 by Italian Society of Invasive Cardiology.
Recruitment status was:  Recruiting
First Posted : April 22, 2016
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
IRCCS Policlinico S. Matteo
Information provided by (Responsible Party):
Italian Society of Invasive Cardiology

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.


Condition or disease
Non ST Elevation Acute Coronary Syndromes Stable Coronary Syndromes NSTEMI Unstable Angina

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease
Study Start Date : October 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Patient with non ST Elevation - Acute Coronary Syndrome
Patient with stable Coronary Artery Disease (CAD)



Primary Outcome Measures :
  1. Proportion of patients with stable Coronary Artery Disease (CAD) whose clinical indication was appropriate for the treatment with Percutaneous Coronary Intervention (PCI). [ Time Frame: 3 months ]
    Appropriateness will be defined by a final score of ≥ 7 of the Central Heart Team according to appropriate use criteria.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 3 months ]
  2. Proportion of patients receiving incomplete revascularization (i.e. residual SYNTAX > 8)Heart Team or in patients without documented ischemia with stable CAD. [ Time Frame: 3 months ]
  3. Proportion of patients receiving guideline-recommended medical therapy at the time of PCI with stable CAD. [ Time Frame: 3 months ]
  4. 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. [ Time Frame: 3 months ]
  5. 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. [ Time Frame: 3 months ]
  6. Proportion of patients treated with PCI whose clinical indication appears appropriate defined by a final score of ≥ 7 of the Heart Team according to appropriate use criteria for Non ST elevation ACS (nSTE-ACS). [ Time Frame: 3 months ]
  7. Proportion of PCI procedures performed within 24 hours of admission in patients with nSTEACS with GRACE> 140 for nSTE-ACS. [ Time Frame: 3 months ]
  8. Proportion of patients with nSTEACS who are stabilized (no recurrent ischemic symptoms) who have multivessel disease and a high SYNTAX score (>22), without documentation of Heart Team discussion in the medical records for nSTE-ACS. [ Time Frame: 3 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion criteria:

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

Exclusion criteria :

  • STEMI at presentation
  • previous CABG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748603


Contacts
Contact: Florinda Maiorana, DBiotech, PHD 0382982105 ext CCRC f.maiorana@smatteo.pv.it
Contact: Diego Rizzotti, DBiotech 0382982105 ext CCRC d.rizzotti@smatteo.pv.it

Locations
Italy
IRCCS Policlinico S. Matteo Recruiting
Pavia, Pv, Italy, 27100
Sponsors and Collaborators
Italian Society of Invasive Cardiology
IRCCS Policlinico S. Matteo
Investigators
Study Chair: Stefano De Servi, MD IRCCS Policlinico S. Matteo
Study Director: Sergio Leonardi, MD IRCCS Policlinico S. Matteo / CCRC - Cardiovascular Clinical Research Center

Study Data/Documents: Report on National Journal  This link exits the ClinicalTrials.gov site
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

Publications of Results:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Italian Society of Invasive Cardiology
ClinicalTrials.gov Identifier: NCT02748603     History of Changes
Other Study ID Numbers: 20140003325
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Syndrome
Heart Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Angina, Unstable
Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms