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ARgentinean Risk Assessment Registry in ACS; the ARRA-RACS Study (ARRA-RACS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377402
First Posted: June 21, 2011
Last Update Posted: May 2, 2017
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. Read our disclaimer for details.
Collaborator:
Universidad Católica de Salta
Information provided by (Responsible Party):
Helse Stavanger HF
  Purpose

The first aim of this trial is to assess the long-term prognostic value of Omega-3 index, which is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to other fatty acids in the erythrocyte membrane, in an unselected, regional multicenter observational study of 982 chest pain patients admitted to the emergency unit, employing blood samples collected at admission.

The second purpose of this study is to evaluate the prognostic utility of vitamin D in the same population.

The third purpose of this study is to assess the incremental prognostic value of B-type natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP).


Condition
Chest Pain Coronary Artery Disease Unstable Angina Pectoris Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ARgentinean Risk Assessment Registry in Acute Coronary Syndrome; the ARRA-RACS Study.

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Total Mortality. [ Time Frame: 2-5 years ]
    Mortality for any reason


Secondary Outcome Measures:
  • Participants With Cardiac Events During Follow-up. [ Time Frame: 2-5 years ]
    Cardiovascular Death. Myocardial infarctions (re-MIs) defined according to WHO criteria of 1979.


Biospecimen Retention:   Samples Without DNA
Serum, Citrated plasma, EDTA-plasma and packed red blood cells are kept in suitable aliquots at -80 degrees Celcius.

Enrollment: 982
Study Start Date: November 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chest pain
Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
982 men and women admitted with chest pain and potential acute cornary syndrome (ACS) at nine hopitals in Salta, Argenitna between November 2005 and November 2008.
Criteria

Inclusion Criteria:

  • adults > 18 years able to give informed consent
  • a history of chest pain or other symptoms suggestive of an ACS leading to admission at the emergency unit

Exclusion Criteria:

  • < 18 years of age
  • Unwillingness or incapacity to provide informed consent
  • Prior admission resulting in inclusion in the present study
  Contacts and Locations
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): NCT01377402


Locations
Argentina
Clinica Güemes
Salta, Argentina, 4400
Clinica San Rafael
Salta, Argentina, 4400
Hospital Militar Salta
Salta, Argentina, 4400
Hospital Privado Santa Clara de Asis
Salta, Argentina, 4400
Hospital San Bernardo
Salta, Argentina, 4400
Intituto CENESA
Salta, Argentina, 4400
Sanatorio El Carmen
Salta, Argentina, 4400
Sanatorio El Parque
Salta, Argentina, 4400
Sanatorio San Roque
Salta, Argentina, 4400
Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4011
Sponsors and Collaborators
Helse Stavanger HF
Universidad Católica de Salta
Investigators
Principal Investigator: Dennis WT Nilsen, MD PhD Prof. Helse Stavanger HF
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01377402     History of Changes
Other Study ID Numbers: ARRA-RACS
First Submitted: June 20, 2011
First Posted: June 21, 2011
Results First Submitted: July 28, 2015
Results First Posted: December 17, 2015
Last Update Posted: May 2, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Chest Pain
Angina Pectoris
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms