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Risk Markers in the Acute Coronary Syndromes (RACS)
This study has been completed.
First Received: August 27, 2007   Last Updated: June 22, 2009   History of Changes
Sponsor: University of Bergen
Collaborators: Stavanger University Hospital
The Royal Norwegian Ministry of Health
Axis-Shield, Dundee, UK
Information provided by: University of Bergen
ClinicalTrials.gov Identifier: NCT00521976
  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: Cohort, Prospective
Official Title: An Investigation of Activated Factor XII (Fxlla) as a Prognostic Marker.

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 University of Bergen:

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 ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521976

Locations
Norway, Rogaland
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4068
Sponsors and Collaborators
University of Bergen
Stavanger University Hospital
The Royal Norwegian Ministry of Health
Axis-Shield, Dundee, UK
Investigators
Principal Investigator: Dennis WT Nilsen, MD PhD FESC University of Bergen, Stavanger University Hospital, Dept. of Cardiology
  More Information

Additional Information:
Regional Ethics Committee  This link exits the ClinicalTrials.gov site
Norwegian Social Science Data Services  This link exits the ClinicalTrials.gov site

Publications:
Ponitz V, Pritchard D, Grundt H, Nilsen DW. Specific types of activated Factor XII increase following thrombolytic therapy with tenecteplase. J Thromb Thrombolysis. 2006 Dec;22(3):199-203.
Ponitz V, Pritchard D, Grundt H, Mehus MB, Nilsen DW. Changes of plasma activated Factor XII type A (XIIaA) concentrations following percutaneous coronary intervention (PCI). J Thromb Thrombolysis. 2007 Oct;24(2):131-5. Epub 2007 May 11.
Brugger-Andersen T, Hetland O, Ponitz V, Grundt H, Nilsen DW. The effect of primary percutaneous coronary intervention as compared to tenecteplase on myeloperoxidase, pregnancy-associated plasma protein A, soluble fibrin and D-dimer in acute myocardial infarction. Thromb Res. 2007;119(4):415-21. Epub 2006 May 2.
Pönitz V, Brügger-Andersen T, Pritchard D, Grundt H, Staines H, Nilsen DW; RACS Study Group. Activated factor XII type A predicts long-term mortality in patients admitted with chest pain. J Thromb Haemost. 2009 Feb;7(2):277-87. Epub 2008 Dec 1.
Brügger-Andersen T, Pönitz V, Staines H, Grundt H, Hetland Ø, Nilsen DW. The prognostic utility of D-dimer and fibrin monomer at long-term follow-up after hospitalization with coronary chest pain. Blood Coagul Fibrinolysis. 2008 Oct;19(7):701-7.
Brügger-Andersen T, Pönitz V, Staines H, Pritchard D, Grundt H, Nilsen DW. B-type natriuretic peptide is a long-term predictor of all-cause mortality, whereas high-sensitive C-reactive protein predicts recurrent short-term troponin T positive cardiac events in chest pain patients: a prognostic study. BMC Cardiovasc Disord. 2008 Nov 25;8:34.
Aarsetøy H, Pönitz V, Nilsen OB, Grundt H, Harris WS, Nilsen DW. Low levels of cellular omega-3 increase the risk of ventricular fibrillation during the acute ischaemic phase of a myocardial infarction. Resuscitation. 2008 Sep;78(3):258-64. Epub 2008 Jun 16.
Aarsetoey H, Pönitz V, Grundt H, Staines H, Harris WS, Nilsen DW. (n-3) Fatty acid content of red blood cells does not predict risk of future cardiovascular events following an acute coronary syndrome. J Nutr. 2009 Mar;139(3):507-13. Epub 2009 Jan 21.
Miller GJ, Esnouf MP, Burgess AI, Cooper JA, Mitchell JP. Risk of coronary heart disease and activation of factor XII in middle-aged men. Arterioscler Thromb Vasc Biol. 1997 Oct;17(10):2103-6.
Zito F, Drummond F, Bujac SR, Esnouf MP, Morrissey JH, Humphries SE, Miller GJ. Epidemiological and genetic associations of activated factor XII concentration with factor VII activity, fibrinopeptide A concentration, and risk of coronary heart disease in men. Circulation. 2000 Oct 24;102(17):2058-62.
Cooper JA, Miller GJ, Bauer KA, Morrissey JH, Meade TW, Howarth DJ, Barzegar S, Mitchell JP, Rosenberg RD. Comparison of novel hemostatic factors and conventional risk factors for prediction of coronary heart disease. Circulation. 2000 Dec 5;102(23):2816-22.
Kohler HP, Carter AM, Stickland MH, Grant PJ. Levels of activated FXII in survivors of myocardial infarction--association with circulating risk factors and extent of coronary artery disease. Thromb Haemost. 1998 Jan;79(1):14-8.
Kohler HP, Carter AM, Stickland MH, Grant PJ. Levels of activated FXII in survivors of myocardial infarction--association with circulating risk factors and extent of coronary artery disease. Thromb Haemost. 1998 Jan;79(1):14-8.
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.
Maeda K, Tsutamoto T, Wada A, Hisanaga T, Kinoshita M. Plasma brain natriuretic peptide as a biochemical marker of high left ventricular end-diastolic pressure in patients with symptomatic left ventricular dysfunction. Am Heart J. 1998 May;135(5 Pt 1):825-32.
Nakagawa O, Ogawa Y, Itoh H, Suga S, Komatsu Y, Kishimoto I, Nishino K, Yoshimasa T, Nakao K. Rapid transcriptional activation and early mRNA turnover of brain natriuretic peptide in cardiocyte hypertrophy. Evidence for brain natriuretic peptide as an "emergency" cardiac hormone against ventricular overload. J Clin Invest. 1995 Sep;96(3):1280-7.
Richards AM, Nicholls MG, Espiner EA, Lainchbury JG, Troughton RW, Elliott J, Frampton C, Turner J, Crozier IG, Yandle TG. B-type natriuretic peptides and ejection fraction for prognosis after myocardial infarction. Circulation. 2003 Jun 10;107(22):2786-92. Epub 2003 May 27.
de Lemos JA, Morrow DA, Bentley JH, Omland T, Sabatine MS, McCabe CH, Hall C, Cannon CP, Braunwald E. The prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes. N Engl J Med. 2001 Oct 4;345(14):1014-21.
Morrow DA, de Lemos JA, Sabatine MS, Murphy SA, Demopoulos LA, DiBattiste PM, McCabe CH, Gibson CM, Cannon CP, Braunwald E. Evaluation of B-type natriuretic peptide for risk assessment in unstable angina/non-ST-elevation myocardial infarction: B-type natriuretic peptide and prognosis in TACTICS-TIMI 18. J Am Coll Cardiol. 2003 Apr 16;41(8):1264-72. Erratum in: J Am Coll Cardiol. 2003 May 21;41(10):1852.
Omland T, Persson A, Ng L, O'Brien R, Karlsson T, Herlitz J, Hartford M, Caidahl K. N-terminal pro-B-type natriuretic peptide and long-term mortality in acute coronary syndromes. Circulation. 2002 Dec 3;106(23):2913-8.
Wang TJ, Larson MG, Levy D, Benjamin EJ, Leip EP, Omland T, Wolf PA, Vasan RS. Plasma natriuretic peptide levels and the risk of cardiovascular events and death. N Engl J Med. 2004 Feb 12;350(7):655-63.
Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. Review. No abstract available.
Liuzzo G, Biasucci LM, Gallimore JR, Grillo RL, Rebuzzi AG, Pepys MB, Maseri A. The prognostic value of C-reactive protein and serum amyloid a protein in severe unstable angina. N Engl J Med. 1994 Aug 18;331(7):417-24.
Berk BC, Weintraub WS, Alexander RW. Elevation of C-reactive protein in "active" coronary artery disease. Am J Cardiol. 1990 Jan 15;65(3):168-72.
de Lemos JA. The latest and greatest new biomarkers: which ones should we measure for risk prediction in our practice? Arch Intern Med. 2006 Dec 11-25;166(22):2428-30. No abstract available. Erratum in: Arch Intern Med. 2007 Feb 26;167(4):353.
Rothenbacher D, Koenig W, Brenner H. Comparison of N-terminal pro-B-natriuretic peptide, C-reactive protein, and creatinine clearance for prognosis in patients with known coronary heart disease. Arch Intern Med. 2006 Dec 11-25;166(22):2455-60.
Kim H, Yang DH, Park Y, Han J, Lee H, Kang H, Park HS, Cho Y, Chae SC, Jun JE, Park WH. Incremental prognostic value of C-reactive protein and N-terminal proB-type natriuretic peptide in acute coronary syndrome. Circ J. 2006 Nov;70(11):1379-84.
Ndrepepa G, Kastrati A, Braun S, Mehilli J, Niemoller K, von Beckerath N, von Beckerath O, Vogt W, Schomig A. N-terminal probrain natriuretic peptide and C-reactive protein in stable coronary heart disease. Am J Med. 2006 Apr;119(4):355.e1-8.
Harris WS, Sands SA, Windsor SL, Ali HA, Stevens TL, Magalski A, Porter CB, Borkon AM. Omega-3 fatty acids in cardiac biopsies from heart transplantation patients: correlation with erythrocytes and response to supplementation. Circulation. 2004 Sep 21;110(12):1645-9. Epub 2004 Sep 7. Erratum in: Circulation. 2004 Nov 9;110(19):3156.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Brügger-Andersen T, Pönitz V, Kontny F, Staines H, Grundt H, Sagara M, Nilsen DW. The long pentraxin 3 (PTX3): a novel prognostic inflammatory marker for mortality in acute chest pain. Thromb Haemost. 2009 Sep;102(3):555-63.

Responsible Party: Stavanger University Hospital ( Dennis W.T. Nilsen MD PhD FESC FAHA, Chief Physician/Professor of Medicine )
Study ID Numbers: NSD9253
Study First Received: August 27, 2007
Results First Received: January 9, 2009
Last Updated: June 22, 2009
ClinicalTrials.gov Identifier: NCT00521976     History of Changes
Health Authority: Norway: The National Committees for Research Ethics in Norway

Keywords provided by University of Bergen:
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:
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Ischemia
Arteriosclerosis
Chest Pain
Coronary Disease
 Signs and Symptoms
Necrosis
Pathologic Processes
Acute Coronary Syndrome
Cardiovascular Diseases
Infarction
Angina, Unstable
Myocardial Infarction
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010



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