Prognostic Models for People With Stable Coronary Artery Disease

NCT01609465 | Unknown DMC

• 1 other identifier: CALIBER 10-13
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 1

Brief Summary

There is currently no published algorithm for secondary prevention prognosis of CHD that is representative of the England GP-registered population and that includes both symptomatic and asymptomatic patients (as identified through primary care). In this paper the investigators will exploit routinely collected information in clinical practice to model CHD prognosis based on a large contemporary open cohort of stable CAD patients. Although the investigators model is based on data from GP practices in England only, the investigators believe that this population is sufficiently heterogeneous in terms of ethnic mix, socioeconomic background, predisposing characteristics and lifestyles to generate a prognostic model with good generalizing power to the wider population. Among the research questions the investigators will try to answer is whether established risk factors for primary care prevention (smoking, hypertension, dyslipidaemia, diabetes) are also reliable for risk-stratification of patients who have already developed CAD. Similarly, the investigators will examine whether strong predictors of adverse outcomes in ACS patients in the short term, such as admission SBP and heart rate, are also associated with their long term prognosis.

Conditions

Stable Coronary Artery Disease

Keywords

CAD; stable angina; STEMI; NSTEMI; CVD; secondary prevention

Study Arms (1)

Stable angina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To define incident cases we will exclude patients who have not been observed during the year prior to their CAD diagnosis date. For prevalent cases we will remove this condition. Our startpoint population is defined as patients aged 18 years or over diagnosed with CAD, under which we include: 1. patients diagnosed with stable angina 2. patients with ACS (STEMI, NSTEMI \& unstable angina) who survived \> 4 weeks. Patients with a CAD diagnosis who received revascularization during follow-up will enter the cohort after the procedure (given post-procedure survival \>4 weeks).

You may qualify if:

• Eligible general practices were defined as practices that meet standards for acceptable levels of data recording (i.e. audits demonstrated that "at least 95% of relevant patient encounters are recorded and data meet quality standards for epidemiological research"7), and have consented to linkage with HES and MINAP (approximately 200 practices).

Sponsors & Collaborators

• University College, London: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Clinical Epidemiology Group, UCL

London, WC1E 7HE, United Kingdom

Location

Related Publications (15)

• Fox KM; EURopean trial On reduction of cardiac events with Perindopril in stable coronary Artery disease Investigators. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet. 2003 Sep 6;362(9386):782-8. doi: 10.1016/s0140-6736(03)14286-9.

  PMID: 13678872 BACKGROUND

• Squizzato A, Keller T, Romualdi E, Middeldorp S. Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular disease. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD005158. doi: 10.1002/14651858.CD005158.pub3.

  PMID: 21249668 BACKGROUND

• Clayton TC, Lubsen J, Pocock SJ, Voko Z, Kirwan BA, Fox KA, Poole-Wilson PA. Risk score for predicting death, myocardial infarction, and stroke in patients with stable angina, based on a large randomised trial cohort of patients. BMJ. 2005 Oct 15;331(7521):869. doi: 10.1136/bmj.38603.656076.63. Epub 2005 Oct 6.

  PMID: 16210253 BACKGROUND

• Roques F, Nashef SA, Michel P, Gauducheau E, de Vincentiis C, Baudet E, Cortina J, David M, Faichney A, Gabrielle F, Gams E, Harjula A, Jones MT, Pintor PP, Salamon R, Thulin L. Risk factors and outcome in European cardiac surgery: analysis of the EuroSCORE multinational database of 19030 patients. Eur J Cardiothorac Surg. 1999 Jun;15(6):816-22; discussion 822-3. doi: 10.1016/s1010-7940(99)00106-2.

  PMID: 10431864 BACKGROUND

• Sutcliffe SJ, Fox KF, Wood DA, Sutcliffe A, Stock K, Wright M, Akhras F, Langford E. Incidence of coronary heart disease in a health authority in London: review of a community register. BMJ. 2003 Jan 4;326(7379):20. doi: 10.1136/bmj.326.7379.20. No abstract available.

  PMID: 12511455 BACKGROUND

• Walley T, Mantgani A. The UK General Practice Research Database. Lancet. 1997 Oct 11;350(9084):1097-9. doi: 10.1016/S0140-6736(97)04248-7. No abstract available.

  PMID: 10213569 BACKGROUND

• Birkhead J, Walker L. National audit of myocardial infarction (MINAP): a project in evolution. Hosp Med. 2004 Aug;65(8):452-3. doi: 10.12968/hosp.2004.65.8.15487. No abstract available.

  PMID: 15330343 BACKGROUND

• White IR, Royston P. Imputing missing covariate values for the Cox model. Stat Med. 2009 Jul 10;28(15):1982-98. doi: 10.1002/sim.3618.

  PMID: 19452569 BACKGROUND

• Wood AM, White IR, Royston P. How should variable selection be performed with multiply imputed data? Stat Med. 2008 Jul 30;27(17):3227-46. doi: 10.1002/sim.3177.

  PMID: 18203127 BACKGROUND

• White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011 Feb 20;30(4):377-99. doi: 10.1002/sim.4067. Epub 2010 Nov 30.

  PMID: 21225900 BACKGROUND

• Prentice RL, Kalbfleisch JD, Peterson AV Jr, Flournoy N, Farewell VT, Breslow NE. The analysis of failure times in the presence of competing risks. Biometrics. 1978 Dec;34(4):541-54.

  PMID: 373811 BACKGROUND

• Wolbers M, Koller MT, Witteman JC, Steyerberg EW. Prognostic models with competing risks: methods and application to coronary risk prediction. Epidemiology. 2009 Jul;20(4):555-61. doi: 10.1097/EDE.0b013e3181a39056.

  PMID: 19367167 BACKGROUND

• Fox KA, Goodman SG, Anderson FA Jr, Granger CB, Moscucci M, Flather MD, Spencer F, Budaj A, Dabbous OH, Gore JM; GRACE Investigators. From guidelines to clinical practice: the impact of hospital and geographical characteristics on temporal trends in the management of acute coronary syndromes. The Global Registry of Acute Coronary Events (GRACE). Eur Heart J. 2003 Aug;24(15):1414-24. doi: 10.1016/s0195-668x(03)00315-4.

  PMID: 12909070 BACKGROUND

• Pencina MJ, D'Agostino RB Sr, Steyerberg EW. Extensions of net reclassification improvement calculations to measure usefulness of new biomarkers. Stat Med. 2011 Jan 15;30(1):11-21. doi: 10.1002/sim.4085. Epub 2010 Nov 5.

  PMID: 21204120 BACKGROUND

• Bhatt DL, Eagle KA, Ohman EM, Hirsch AT, Goto S, Mahoney EM, Wilson PW, Alberts MJ, D'Agostino R, Liau CS, Mas JL, Rother J, Smith SC Jr, Salette G, Contant CF, Massaro JM, Steg PG; REACH Registry Investigators. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010 Sep 22;304(12):1350-7. doi: 10.1001/jama.2010.1322. Epub 2010 Aug 30.

  PMID: 20805624 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Harry Hemingway, FRCP

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Epidemiology

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: June 1, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

GB (1)