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

NCT01377402 | Completed Results DMC

• 1 other identifier: ARRA-RACS
• Study Type: observational
• Target: 982
• Locations: 2 countries
• Sites: 10

Brief Summary

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).

Conditions

Chest Pain; Coronary Artery Disease; Unstable Angina Pectoris; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Total Mortality.

  Mortality for any reason

  2-5 years

Secondary Outcomes (1)

• Participants With Cardiac Events During Follow-up.

  2-5 years

Study Arms (1)

Chest pain

Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \< 18 years of age
• Unwillingness or incapacity to provide informed consent

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Universidad Católica de Salta: collaborator

Study Sites (10)

Clinica Güemes

Salta, Salta Province, 4400, Argentina

Location

Clinica San Rafael

Salta, Salta Province, 4400, Argentina

Location

Hospital Militar Salta

Salta, Salta Province, 4400, Argentina

Location

Hospital Privado Santa Clara de Asis

Salta, Salta Province, 4400, Argentina

Location

Hospital San Bernardo

Salta, Salta Province, 4400, Argentina

Location

Intituto CENESA

Salta, Salta Province, 4400, Argentina

Location

Sanatorio El Carmen

Salta, Salta Province, 4400, Argentina

Location

Sanatorio El Parque

Salta, Salta Province, 4400, Argentina

Location

Sanatorio San Roque

Salta, Salta Province, 4400, Argentina

Location

Stavanger University Hospital

Stavanger, Rogaland, 4011, Norway

Location

Related Publications (8)

• Leon 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. doi: 10.1186/1471-2261-11-57.

  PMID: 21958326 RESULT

• de la Fuente RL, Naesgaard PA, Nilsen ST, Woie L, Aarsland T, Gundersen T, Nilsen DW. Omega-3 index and prognosis in acute coronary chest pain patients with a low dietary intake of omega-3. Scand Cardiovasc J. 2013 Apr;47(2):69-79. doi: 10.3109/14017431.2012.747220. Epub 2012 Dec 12.

  PMID: 23127172 RESULT

• Leon de la Fuente RA, Naesgaard PA, Nilsen ST, Woie L, Aarsland T, Staines H, Nilsen DW. Socioeconomic assessment and impact of social security on outcome in patients admitted with suspected coronary chest pain in the city of salta, Argentina. Cardiol Res Pract. 2013;2013:807249. doi: 10.1155/2013/807249. Epub 2013 May 29.

  PMID: 23819097 RESULT

• Naesgaard PA, Leon de la Fuente RA, Nilsen ST, Woie L, Aarsland T, Staines H, Nilsen DW. Vitamin d predicts all-cause and cardiac mortality in females with suspected acute coronary syndrome: a comparison with brain natriuretic Peptide and high-sensitivity C-reactive protein. Cardiol Res Pract. 2013;2013:398034. doi: 10.1155/2013/398034. Epub 2013 Nov 17.

  PMID: 24349821 RESULT

• Nilsen DW, Mjelva OR, Leon de la Fuente RA, Naesgaard P, Ponitz V, Brugger-Andersen T, Grundt H, Staines H, Nilsen ST. Borderline Values of Troponin-T and High Sensitivity C-Reactive Protein Did Not Predict 2-Year Mortality in TnT Positive Chest-Pain Patients, Whereas Brain Natriuretic Peptide Did. Front Cardiovasc Med. 2015 Apr 8;2:16. doi: 10.3389/fcvm.2015.00016. eCollection 2015.

  PMID: 26664888 RESULT

• Aarsetoy R, Ueland T, Aukrust P, Michelsen AE, Leon de la Fuente R, Grundt H, Staines H, Nygaard O, Nilsen DWT. Complement component 7 is associated with total- and cardiac death in chest-pain patients with suspected acute coronary syndrome. BMC Cardiovasc Disord. 2021 Oct 14;21(1):496. doi: 10.1186/s12872-021-02306-w.

  PMID: 34649504 DERIVED

• Aarsetoy R, Ueland T, Aukrust P, Michelsen AE, de la Fuente RL, Ponitz V, Brugger-Andersen T, Grundt H, Staines H, Nilsen DWT. Angiopoietin-2 and angiopoietin-like 4 protein provide prognostic information in patients with suspected acute coronary syndrome. J Intern Med. 2021 Oct;290(4):894-909. doi: 10.1111/joim.13339. Epub 2021 Jul 8.

  PMID: 34237166 DERIVED

• Naesgaard PA, Leon 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.

  PMID: 22970121 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Citrated plasma, EDTA-plasma and packed red blood cells are kept in suitable aliquots at -80 degrees Celcius.

MeSH Terms

Conditions

Chest Pain; Coronary Artery Disease; Angina, Unstable; Myocardial Infarction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Infarction; Ischemia; Pathologic Processes; Necrosis

Results Point of Contact

• Title: Dennis WT Nilsen, MD, phd, professor
• Organization: Stavanger University Hospital

dnilsen1@getmail.no

+4795777735

Study Officials

• Dennis WT Nilsen, MD PhD Prof.

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 21, 2011
• Study Start: November 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 2, 2017
• Results First Posted: December 17, 2015

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (9); NO (1)