Risk Markers in the Acute Coronary Syndromes (RACS)

This study has been completed.
Sponsor:
Collaborators:
Helse Vest
Axis-Shield, Dundee, UK
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00521976
First received: August 27, 2007
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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
Chest Pain
Coronary Artery Disease
Unstable Angina Pectoris
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Investigation of Activated Factor XII (Fxlla) as a Prognostic Marker.

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Total Mortality. [ Time Frame: 24 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrent Troponin-T (TnT) Positive Events [ Time Frame: 24 months. ] [ Designated as safety issue: No ]
    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.


Enrollment: 871
Study Start Date: November 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (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

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.

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: NCT00521976

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

Additional Information:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00521976     History of Changes
Other Study ID Numbers: NSD9253
Study First Received: August 27, 2007
Results First Received: January 9, 2009
Last Updated: November 5, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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)
Omega-3

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

ClinicalTrials.gov processed this record on October 19, 2014