Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02748603
Status:
UNKNOWN
Last Update Posted:
2016-04-27
First Post:
2016-04-11
Brief Title:
Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease
Sponsor:
Italian Society of Invasive Cardiology
Organization:
Italian Society of Invasive Cardiology
Study Overview
Official Title:
Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APACHE
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 41 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
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
Detailed Description:
A strategy based on early invasive coronary angiography followed by revascularization is the most effective treatment of patients with acute coronary syndrome especially in those with ST-segment elevation STE-ACS In patients with acute coronary syndrome without ST-segment elevation NSTE-ACS an early invasive strategy is associated with a reduction in cardiac death and myocardial infarction in patients at higher risk In stable coronary artery disease rather no data so convincing The undeniable evolution of techniques of PCI has been accompanied by a parallel progress of medical therapy and also from increased awareness both cardiologists and patients the importance of the control of coronary risk factors
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None