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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01377402
First received: June 20, 2011
Last updated: January 4, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrent Troponin-T (TnT) Positive Events [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377402

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

Publications:
Additional 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
Study First Received: June 20, 2011
Last Updated: January 4, 2014
Health Authority: Norway: Ministry of Health and Care Services

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

ClinicalTrials.gov processed this record on July 22, 2014