The International Survey of Acute Coronary Syndromes-ARCHIVES

NCT04008173 | Enrolling By Invitation DMC

• 1 other identifier: University of Bologna
• Study Type: observational
• Target: 130,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Coronary Syndrome; Coronary Disease; Unstable Angina Pectoris; Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Cardiovascular death

  up to 1 year

• Recurrent myocardial infarction

  up to 1 year

• Pharmacogenomics

  up to 1 year

• Cardiovascular genetics of coronary heart disease

  up to 1 year

Study Arms (5)

Male

Non-interventional patient registry

Other: Non-interventional patient registry

Female

Non-interventional patient registry

Other: Non-interventional patient registry

Kidney Disease

Non-interventional patient registry

Other: Non-interventional patient registry

Diabetes

Non-interventional patient registry

Other: Non-interventional patient registry

Elderly

Non-interventional patient registry

Other: Non-interventional patient registry

Interventions

Non-interventional patient registry OTHER

Non-interventional patient registry

Diabetes; Elderly; Female; Kidney Disease; Male

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects admitted with a diagnosis of acute coronary syndromes

You may qualify if:

• acute coronary syndromes

You may not qualify if:

• under age or not able to give informed consent

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

University of Bologna

Bologna, Bologna, 40138, Italy

Location

Related Publications (4)

• 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.

  PMID: 32654558 RESULT

• 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.

  PMID: 34251454 RESULT

• 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.

  PMID: 34233252 RESULT

• 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.

  PMID: 35589164 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Unstable; Myocardial Infarction; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Raffaele Bugiardini, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Cardiology

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 5, 2019
• Study Start: June 28, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

IT (1)