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

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:

MedlinePlus related topics: Angina Chest Pain Coronary Artery Disease Heart Attack

U.S. FDA Resources

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

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:

León de la Fuente R, Naesgaard PA, Nilsen ST, Woie L, Aarsland T, Gallo P, Grundt H, Staines H, Nilsen DW. B-type natriuretic peptide and high sensitive C-reactive protein predict 2-year all cause mortality in chest pain patients: a prospective observational study from Salta, Argentina. BMC Cardiovasc Disord. 2011 Sep 29;11:57.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Naesgaard PA, León De La Fuente RA, Nilsen ST, Woie L, Aarsland T, Brede C, Staines H, Nilsen DW. Serum 25(OH)D is a 2-year predictor of all-cause mortality, cardiac death and sudden cardiac death in chest pain patients from Northern Argentina. PLoS One. 2012;7(9):e43228. doi: 10.1371/journal.pone.0043228. Epub 2012 Sep 6.

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:	August 9, 2012
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 May 21, 2013