Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04008173
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Raffaele Bugiardini, University of Bologna

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).

Condition or disease Intervention/treatment
Acute Coronary Syndrome Unstable Angina Pectoris Myocardial Infarction Coronary Disease Other: Non-interventional patient registry

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 130000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The International Survey of Acute Coronary Syndromes- ARCHIVES
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : June 28, 2022
Estimated Study Completion Date : June 28, 2022

Group/Cohort Intervention/treatment
Male Other: Non-interventional patient registry
Non-interventional patient registry

Female Other: Non-interventional patient registry
Non-interventional patient registry

Kidney Disease Other: Non-interventional patient registry
Non-interventional patient registry

Diabetes Other: Non-interventional patient registry
Non-interventional patient registry

Elderly Other: Non-interventional patient registry
Non-interventional patient registry




Primary Outcome Measures :
  1. All causes death [ Time Frame: 30 days ]
    All causes death

  2. All causes death [ Time Frame: 6 months ]
    All causes death

  3. All causes death [ Time Frame: 1 year ]
    All causes death


Secondary Outcome Measures :
  1. Cardiovascular death [ Time Frame: up to 1 year ]
    Cardiovascular death

  2. Recurrent myocardial infarction [ Time Frame: up to 1 year ]
    A disorder characterized by signs and symptoms related to acute ischemia of the myocardium secondary to coronary artery disease

  3. Pharmacogenomics [ Time Frame: up to 1 year ]
    DNA sequence data to predict drug response and to inform drug discovery and development

  4. Cardiovascular genetics of coronary heart disease [ Time Frame: up to 1 year ]
    Common variant genotyping for risk prediction


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects admitted with a diagnosis of acute coronary syndromes
Criteria

Inclusion Criteria:

  • acute coronary syndromes

Exclusion Criteria:

  • under age or not able to give informed consent

Information from the National Library of Medicine

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): NCT04008173


Contacts
Layout table for location contacts
Contact: Raffaele Bugiardini, MD +39 335 5612962 raffaele.bugiardini@unibo.it

Locations
Layout table for location information
Italy
University of Bologna Recruiting
Bologna, Italy, 40138
Contact: Raffaele Bugiardini, MD    +393355612962    raffaele.bugiardini@unibo.it   
Sponsors and Collaborators
University of Bologna

Layout table for additonal information
Responsible Party: Raffaele Bugiardini, Full Professor of Cardiology, University of Bologna
ClinicalTrials.gov Identifier: NCT04008173     History of Changes
Other Study ID Numbers: University of Bologna
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chest Pain
Pain
Myocardial Infarction
Acute Coronary Syndrome
Coronary Disease
Angina Pectoris
Angina, Unstable
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms