Risk Markers in the Acute Coronary Syndromes - Study Results

Study Type:	Observational
Study Design:	Cohort, Prospective
Conditions:	Chest Pain Coronary Artery Disease Unstable Angina Pectoris Myocardial Infarction

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Consecutive recruitment at Stavanger University Hospital.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Group 1	Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)

Participant Flow: Overall Study

	Group 1
STARTED	871
COMPLETED	871
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Group 1	Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)

Baseline Measures

	Group 1
Number of Participants [units: participants]	871
Age [units: participants]
<=18 years	0
Between 18 and 65 years	300
>=65 years	571
Age [units: years] Mean ± Standard Deviation	69.6 ± 14.4
Gender [units: participants]
Female	340
Male	531
Region of Enrollment [units: participants]
Norway	871

Outcome Measures

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1. Primary:

Total Mortality. [ 24 months. ]

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2. Secondary:

Recurrent Troponin-T (TnT) Positive Events [ 24 months. ]

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Measure Type	Secondary
Measure Title	Recurrent Troponin-T (TnT) Positive Events
Measure Description	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
Time Frame	24 months.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Group 1	Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)

Measured Values

	Group 1
Number of Participants Analyzed [units: participants]	871
Recurrent Troponin-T (TnT) Positive Events [units: Participants]	155

No statistical analysis provided for Recurrent Troponin-T (TnT) Positive Events

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dennis W.T. Nilsen MD PhD FESC FAHA, Director Div of Interventional Cardiology
Organization: Stavanger University Hospital
phone: +4705151 ext 9455
e-mail: nide@sus.no

Publications of Results:

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.

Other Publications:

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.

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.

Publications automatically indexed to this study:

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