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Risk Markers in the Acute Coronary Syndromes (RACS)

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. Identifier: NCT00521976
Recruitment Status : Completed
First Posted : August 28, 2007
Results First Posted : August 11, 2009
Last Update Posted : June 15, 2015
Helse Vest
Axis-Shield, Dundee, UK
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:

The main aim of this trial is to assess the long-term prognostic value of different types of Factor XIIa in an unselected, single center series of 871 chest pain patients admitted to the emergency unit, employing blood samples collected at admission.

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

A third purpose of this study is to evaluate the prognostic impact of the Omega-3 Index which is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to other fatty acids in the erythrocyte membrane.

Condition or disease
Chest Pain Coronary Artery Disease Unstable Angina Pectoris Myocardial Infarction

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 871 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Investigation of Activated Factor XII (Fxlla) as a Prognostic Marker.
Study Start Date : November 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

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

Primary Outcome Measures :
  1. Total Mortality. [ Time Frame: 24 months. ]

Secondary Outcome Measures :
  1. Recurrent Troponin-T (TnT) Positive Events [ Time Frame: 24 months. ]
    Recurrent Troponin-T (TnT) positive events; Symptoms of coronary ischemia associated with TnT >0.05 ng/mL with a pattern of gradual rise and fall in TnT

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

Information from the National Library of Medicine

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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
871 men and women admitted with chest pain and potential acute cornary syndrome (ACS) at the Stavanger University Hospital between November 2002 and October 2003.

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

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 identifier (NCT number): NCT00521976

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Stavanger University Hospital
Stavanger, Rogaland, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
Helse Vest
Axis-Shield, Dundee, UK
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Principal Investigator: Dennis WT Nilsen, MD PhD FESC Stavanger University Hospital, Dept. of Cardiology

Additional Information:
Publications of Results:

Other Publications:
Pritchard D, Polwart R. In-vivo, activated factor XII exists in multiple forms, but predominantly as a 53 kD Species. J Thromb and Haemost 2005; Suppl.1; ISSN 1740-3340.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Helse Stavanger HF Identifier: NCT00521976     History of Changes
Other Study ID Numbers: NSD9253
First Posted: August 28, 2007    Key Record Dates
Results First Posted: August 11, 2009
Last Update Posted: June 15, 2015
Last Verified: May 2015
Keywords provided by Helse Stavanger HF:
Risk assessment
Chest pain
Coronary Artery Disease
Acute coronary syndromes
Factor XIIa
B-type natriuretic peptide (BNP)
high-sensitive C-reactive protein (hsCRP)
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Angina, Unstable
Chest Pain
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms