Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04008173
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-28
First Post:
2019-06-28
Brief Title:
The International Survey of Acute Coronary Syndromes-ARCHIVES
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
The International Survey of Acute Coronary Syndromes-ARCHIVES
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
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:
ISACS-ARCHIVES
Brief Summary:
ISACS ARCHIVES network is part of ISACS TC NCT01218776 health care program It is a collaborative network of research centers that support the rapid development of new scientific information and analytic tools The ISACS ARCHIVES network assists health care providers scientists and policymakers seeking unbiased information about the outcomes clinical effectiveness safety and appropriateness of health care items and services particularly prescription medications and medical devices in acute coronary syndromes ACS
Detailed Description:
Purpose
ISACS-TC investigators may deposit to the ISACS ARCHIVES their registry data acquired prior to the first submitted date of ISACS-TC at ClinicalTrialsgov October 7 2010 Non- ISACS investigators with ACS data are welcome to deposit their data to the ISACS ARCHIVES as well In this case the data may have been acquired prior or later than October 7 2010 The data in the ISACS ARCHIVES will be catalogued and made available to the general research community The ISACS ARCHIVES will use an established informatics infrastructure hosted and managed by the ISACS TC NCT01218776 and the Department of Electrical and Computer Engineering University of California Los Angeles California which will enable the sharing and use of data The NIH Gov Registration number for the ISACS ARCHIVES will serve as the key for ACS related data submissions to the contact persons
Applicable Data The ISACS ARCHIVES will accept only de-identified data from human subjects studies on ACS for a definition of human subjects see httpshumansubjectsnihgovglossary This will include data from clinical trials epidemiological surveys and other types of studies involving human subjects Databases with significant genomic data eg genome-wide association studies medical sequencing molecular diagnostic assays are expected to be deposited as well Likewise physical bio-samples can be included in the ISACS ARCHIVES
Data Sharing Procedures Data submitted to the ISACS ARCHIVES must be de-identified by the investigator prior to submission Submitted data will be subjected to algorithms that check for basic data accuracy Any problematic data items will be summarized in a report and returned to the investigator for corrective action if necessary before data are accepted Data will be made available for sharing with general research community 2 months after the deposit This 2-month embargo period will provide study investigators with protected time to check for basic data accuracy After the embargo the data will be made available for sharing with the general research community Investigators will be able to gain access to ISACS ARCHIVES data by submitting a data access request to ISACS TC NCT01218776 contact persons Data requests will be reviewed by an ISACS ARCHIVES Data Access Committee The Department of Electrical and Computer Engineering University of California Los Angeles California will collect data
ISACS Data Archive Sharing The following is a summary of tasks and expectations related to submitting data to the ISACS ARCHIVES The purpose of this summary is to provide an overview of data submission and data sharing via the ISACS ARCHIVES This list only provides a summary of tasks
Investigators are expected to
1 Collect Personally Identifiable Information PII from research subjects that will allow for the creation of the ISACS ARCHIVES Global Unique Identifier
2 Provide a de-identified subject ID which is required for submission of data to the ISACS ARCHIVES
3 Complete and submit a Data-Sharing Agreement and Permission DSAP to ISACS TC NCT01218776 contact persons
4 Review the ISACS TC data definition for the measuresexperiments expected and define the projects data definition harmonized to that standard
5 Work with ISACS TC NCT01218776 contact persons to define any undefined measures in accordance with ISACS TC practices
6 Specify the expected measures to be collected by the project in a summary table to be forwarded to the ISACS TC NCT01218776 contact persons
7 Address any post submission quality assurance and quality control QAQC checks that have been identified by the ISACS TC NCT01218776
8 Create an ISACS ARCHIVES Library linking a result from a publication pipeline or discovery of the data sent to ISACS ARCHIVES to its records for publications of results
Policy Implementation ISACS ARCHIVES expects investigators and their institutions to provide basic plans for policy implementation
At present PI Study Investigators
ISACS TC International Survey of Acute Coronary Syndromes in Transitional Countries ClinicalTrialsgov Identifier NCT01218776 from October 2010 to present Contact person Raffaele Bugiardini MD University of Bologna email raffaelebugiardiniuniboit
HORACS hospital registry for acute coronary syndrome in Serbia from January 2002 to September 2010 Contact person Zorana Vasiljevic MD Medical Faculty University of Belgrade email zoranaveunetrs
EMMACE-3 X Long-term Follow-up of Health-Related Quality of Life in Patients With Acute Coronary Syndrome ClinicalTrialsgov Identifier NCT01955525 during the period of 2011 to 2013 Contact person Chris P Gale University of Leeds email cpgaleleedsacuk
ISACS ARCHIVES Data Access Committee
Raffaele Bugiardini University of Bologna Principal Investigator
Chris P Gale University of Leeds
Olivia Manfrini University of Bologna
Lina Badimon Cardiovascular Research Institute ICCC CiberCV-Institute Carlos III IIB-Sant Pau Hospital de la Santa Creu i Sant Pau Autonomous University of Barcelona
Mihaela van der Schaar University of Cambridge
ISACS ARCHIVES Data Sharing Coordinators
Edina Cenko University of Bologna
Jinsung Yoon Department of Electrical and Computer Engineering University of California Los Angeles
Sponsor University of Bologna
Inquiries
Please direct all inquiries to
Principal Investigator Raffaele Bugiardini MD University of Bologna
ISACS-TC investigators may deposit to the ISACS ARCHIVES their registry data acquired prior to the first submitted date of ISACS-TC at ClinicalTrialsgov October 7 2010 Non- ISACS investigators with ACS data are welcome to deposit their data to the ISACS ARCHIVES as well In this case the data may have been acquired prior or later than October 7 2010 The data in the ISACS ARCHIVES will be catalogued and made available to the general research community The ISACS ARCHIVES will use an established informatics infrastructure hosted and managed by the ISACS TC NCT01218776 and the Department of Electrical and Computer Engineering University of California Los Angeles California which will enable the sharing and use of data The NIH Gov Registration number for the ISACS ARCHIVES will serve as the key for ACS related data submissions to the contact persons
Applicable Data The ISACS ARCHIVES will accept only de-identified data from human subjects studies on ACS for a definition of human subjects see httpshumansubjectsnihgovglossary This will include data from clinical trials epidemiological surveys and other types of studies involving human subjects Databases with significant genomic data eg genome-wide association studies medical sequencing molecular diagnostic assays are expected to be deposited as well Likewise physical bio-samples can be included in the ISACS ARCHIVES
Data Sharing Procedures Data submitted to the ISACS ARCHIVES must be de-identified by the investigator prior to submission Submitted data will be subjected to algorithms that check for basic data accuracy Any problematic data items will be summarized in a report and returned to the investigator for corrective action if necessary before data are accepted Data will be made available for sharing with general research community 2 months after the deposit This 2-month embargo period will provide study investigators with protected time to check for basic data accuracy After the embargo the data will be made available for sharing with the general research community Investigators will be able to gain access to ISACS ARCHIVES data by submitting a data access request to ISACS TC NCT01218776 contact persons Data requests will be reviewed by an ISACS ARCHIVES Data Access Committee The Department of Electrical and Computer Engineering University of California Los Angeles California will collect data
ISACS Data Archive Sharing The following is a summary of tasks and expectations related to submitting data to the ISACS ARCHIVES The purpose of this summary is to provide an overview of data submission and data sharing via the ISACS ARCHIVES This list only provides a summary of tasks
Investigators are expected to
1 Collect Personally Identifiable Information PII from research subjects that will allow for the creation of the ISACS ARCHIVES Global Unique Identifier
2 Provide a de-identified subject ID which is required for submission of data to the ISACS ARCHIVES
3 Complete and submit a Data-Sharing Agreement and Permission DSAP to ISACS TC NCT01218776 contact persons
4 Review the ISACS TC data definition for the measuresexperiments expected and define the projects data definition harmonized to that standard
5 Work with ISACS TC NCT01218776 contact persons to define any undefined measures in accordance with ISACS TC practices
6 Specify the expected measures to be collected by the project in a summary table to be forwarded to the ISACS TC NCT01218776 contact persons
7 Address any post submission quality assurance and quality control QAQC checks that have been identified by the ISACS TC NCT01218776
8 Create an ISACS ARCHIVES Library linking a result from a publication pipeline or discovery of the data sent to ISACS ARCHIVES to its records for publications of results
Policy Implementation ISACS ARCHIVES expects investigators and their institutions to provide basic plans for policy implementation
At present PI Study Investigators
ISACS TC International Survey of Acute Coronary Syndromes in Transitional Countries ClinicalTrialsgov Identifier NCT01218776 from October 2010 to present Contact person Raffaele Bugiardini MD University of Bologna email raffaelebugiardiniuniboit
HORACS hospital registry for acute coronary syndrome in Serbia from January 2002 to September 2010 Contact person Zorana Vasiljevic MD Medical Faculty University of Belgrade email zoranaveunetrs
EMMACE-3 X Long-term Follow-up of Health-Related Quality of Life in Patients With Acute Coronary Syndrome ClinicalTrialsgov Identifier NCT01955525 during the period of 2011 to 2013 Contact person Chris P Gale University of Leeds email cpgaleleedsacuk
ISACS ARCHIVES Data Access Committee
Raffaele Bugiardini University of Bologna Principal Investigator
Chris P Gale University of Leeds
Olivia Manfrini University of Bologna
Lina Badimon Cardiovascular Research Institute ICCC CiberCV-Institute Carlos III IIB-Sant Pau Hospital de la Santa Creu i Sant Pau Autonomous University of Barcelona
Mihaela van der Schaar University of Cambridge
ISACS ARCHIVES Data Sharing Coordinators
Edina Cenko University of Bologna
Jinsung Yoon Department of Electrical and Computer Engineering University of California Los Angeles
Sponsor University of Bologna
Inquiries
Please direct all inquiries to
Principal Investigator Raffaele Bugiardini MD University of Bologna
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None