The International Survey of Acute Coronary Syndromes-ARCHIVES (ISACS-ARCHIVES)

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Myocardial Infarction; Coronary Disease; Acute Coronary Syndrome; Unstable Angina Pectoris
• Intervention / Treatment: Other: Non-interventional patient registry

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 ClinicalTrials.gov (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: https://humansubjects.nih.gov/glossary). This will include data from clinical trials, epidemiological surveys, and other types of studies involving human subjects. Databases with significant genomic data (e.g., 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 measures/experiments expected and define the project's 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 (QA/QC) 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 (ClinicalTrials.gov Identifier NCT01218776) from October 2010 to present. Contact person: Raffaele Bugiardini, MD University of Bologna email raffaele.bugiardini@unibo.it
• 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 zoranav@eunet.rs
• EMMACE-3 X. Long-term Follow-up of Health-Related Quality of Life in Patients With Acute Coronary Syndrome (ClinicalTrials.gov Identifier NCT01955525) during the period of 2011 to 2013. Contact person: Chris P Gale University of Leeds email c.p.gale@leeds.ac.uk

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 Type: Observational
• Enrollment (Estimated): 130000

Contacts and Locations

• Study Contact: Name: Raffaele Bugiardini, MD; Phone Number: +39 335 5612962; Email: raffaele.bugiardini@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • University of Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects admitted with a diagnosis of acute coronary syndromes

Description

Inclusion Criteria:

• acute coronary syndromes

Exclusion Criteria:

• under age or not able to give informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Male; Non-interventional patient registry	Other: Non-interventional patient registry; Non-interventional patient registry
Female; Non-interventional patient registry	Other: Non-interventional patient registry; Non-interventional patient registry
Kidney Disease; Non-interventional patient registry	Other: Non-interventional patient registry; Non-interventional patient registry
Diabetes; Non-interventional patient registry	Other: Non-interventional patient registry; Non-interventional patient registry
Elderly; Non-interventional patient registry	Other: Non-interventional patient registry; Non-interventional patient registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All causes death	All causes death	30 days
All causes death	All causes death	6 months
All causes death	All causes death	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Cardiovascular death	up to 1 year
Recurrent myocardial infarction	A disorder characterized by signs and symptoms related to acute ischemia of the myocardium secondary to coronary artery disease	up to 1 year
Pharmacogenomics	DNA sequence data to predict drug response and to inform drug discovery and development	up to 1 year
Cardiovascular genetics of coronary heart disease	Common variant genotyping for risk prediction	up to 1 year

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Raffaele Bugiardini, MD, University of Bologna

Publications and helpful links

General Publications

• Bugiardini R, Yoon J, Kedev S, Stankovic G, Vasiljevic Z, Milicic D, Manfrini O, van der Schaar M, Gale CP, Badimon L, Cenko E. Prior Beta-Blocker Therapy for Hypertension and Sex-Based Differences in Heart Failure Among Patients With Incident Coronary Heart Disease. Hypertension. 2020 Sep;76(3):819-826. doi: 10.1161/HYPERTENSIONAHA.120.15323. Epub 2020 Jul 13.
• Bugiardini R, Cenko E, Yoon J, van der Schaar M, Kedev S, Gale CP, Vasiljevic Z, Bergami M, Milicic D, Zdravkovic M, Krljanac G, Badimon L, Manfrini O. Concerns about the use of digoxin in acute coronary syndromes. Eur Heart J Cardiovasc Pharmacother. 2022 Aug 11;8(5):474-482. doi: 10.1093/ehjcvp/pvab055.
• Vasiljevic Z, Scarpone M, Bergami M, Yoon J, van der Schaar M, Krljanac G, Asanin M, Davidovic G, Simovic S, Manfrini O, Mickovski-Katalina N, Badimon L, Cenko E, Bugiardini R. Smoking and sex differences in first manifestation of cardiovascular disease. Atherosclerosis. 2021 Aug;330:43-51. doi: 10.1016/j.atherosclerosis.2021.06.909. Epub 2021 Jun 26.
• Bugiardini R, Yoon J, Mendieta G, Kedev S, Zdravkovic M, Vasiljevic Z, Milicic D, Manfrini O, van der Schaar M, Gale CP, Bergami M, Badimon L, Cenko E. Reduced Heart Failure and Mortality in Patients Receiving Statin Therapy Before Initial Acute Coronary Syndrome. J Am Coll Cardiol. 2022 May 24;79(20):2021-2033. doi: 10.1016/j.jacc.2022.03.354.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Disease; Chest Pain; Myocardial Infarction; Infarction; Coronary Disease; Syndrome; Acute Coronary Syndrome; Angina Pectoris; Angina, Unstable
• Other Study ID Numbers: University of Bologna

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No