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
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|
|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|
|Patient with non ST Elevation - Acute Coronary Syndrome|
|Patient with stable Coronary Artery Disease (CAD)|
- 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.
- 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 ]
- 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 ]
- Proportion of patients receiving guideline-recommended medical therapy at the time of PCI with stable CAD. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 3 months ]
- 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 ]
- Proportion of PCI procedures performed within 24 hours of admission in patients with nSTEACS with GRACE> 140 for nSTE-ACS. [ Time Frame: 3 months ]
- 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 ]
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
|Contact: Florinda Maiorana, DBiotech, PHD||0382982105 ext CCRCfirstname.lastname@example.org|
|Contact: Diego Rizzotti, DBiotech||0382982105 ext CCRCemail@example.com|
|IRCCS Policlinico S. Matteo||Recruiting|
|Pavia, Pv, Italy, 27100|
|Study Chair:||Stefano De Servi, MD||IRCCS Policlinico S. Matteo|
|Study Director:||Sergio Leonardi, MD||IRCCS Policlinico S. Matteo / CCRC - Cardiovascular Clinical Research Center|