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The purpose of this workshop is to examine the state of the science and to determine what additional basic, clinical, population, and cross-cutting research is needed on the role of C-Reactive Protein (CRP) as a biomarker, a risk factor, and/or treatment target for cardiovascular disease (CVD), in the broader context of the general role of lipids, inflammation, and other mechanisms for atherosclerosis and CVD.

The workshop will address the research needed to enable answering a range of questions including: Through what basic biological mechanisms may CRP affect CVD? Is CRP a causal factor for CVD or a biomarker of inflammation? What additional research is needed to determine the proper role of CRP measurement in CVD prevention and management?

The agenda aims to span basic, clinical, and population sciences, to balance various viewpoints and allow time for discussion, to aim for a cross-cutting perspective, and to obtain direction for future research from the expert community.

Day One Agenda - July 10, 2006

Introduction and Background - Moderator: Scott Grundy

8:30 a.m. - Welcome – Elizabeth Nabel and Denise Simons-Morton
8:45 a.m. - Introduction to the issues and purpose of the workshop - Scott Grundy
9:00 a.m. - Human C-Reactive Protein Overview: Properties and Clinical Behaviour - Mark Pepys

Session 1. Observational Epidemiologic Studies and Clinical Trials - Moderator: Aaron Folsom

This session will examine the role of CRP in predicting CVD risk from epidemiologic studies, including associations and dose-response relationships, the possible independence of CRP as a risk factor for CVD, and the role of CRP in global risk assessment. The session will examine data from clinical trials that have measured CRP in the context of interventions to lower lipids/CVD risk factors.

9:40 a.m. - Epidemiology of CRP and coronary heart disease: an overview - John Danesh
10:00 a.m. - Epidemiology of markers of inflammation and CVD: Why CRP? - Wolfgang Koenig
10:20 a.m. - CVD risk assessment and risk prediction: what does CRP add? - Peter Wilson
10:40 a.m. - Break
11:00 a.m. - Data on hsCRP from clinical trials - Paul Ridker
11:20 a.m. - Statistical issues in interpreting CRP data - Nancy Cook
11:40 a.m. - Statistical Issues in the Interpretation of Risk Prediction Markers - Margaret Pepe
12:00 noon - Lunch
1:00 p.m. - Sleep apnea, sleep deprivation and C-reactive protein – Virend Somers
1:20 p.m. - CRP and lifestyle factors: how modifiable is CRP by changes in adiposity and lifestyle behaviors? – JoAnn Manson
2:00 p.m. - Discussion Panel: Ralph d’Agostino, John Danesh, Wolfgang Koenig, Peter Wilson, Paul Ridker, Chris O’Donnell, James de Lemos, JoAnn Manson, Christie Ballantyne
2:50 p.m. - Break

Session 2. Biology and Measurement of CRP - Moderator: Mary Cushman

This session will examine biological mechanisms by which CRP may affect atherosclerosis and CVD, the role of CRP in the context of inflammatory processes, the genetics/genomics of CRP in relation to CVD, and approaches and accuracy/variability in CRP measurement.

3:20 p.m. - CRP measurement: methods, accuracy, and variability – Russell Tracy
3:40 p.m. - Inflammation and Orchestration of the Acute Phase Response – Peter Libby
4:00 p.m. - Does CRP Participate In Atherothrombosis? (summary not available) – Ishwarlal (Kenny) Jialal
4:20 p.m. - CRP gene polymorphisms associated with differences in blood CRP and disease risk – Alexander Szalai
4:40 p.m. - Discussion Panel: Mary Cushman, Peter Libby, Russell Tracy, Mark Pepys, Ishwarlal Jialal, Alexander Szalai
5:30 p.m. - Wrap up of Day One – Scott Grundy and Aaron Folsom

Day Two Agenda - July 11, 2006

Session 3. Linking Biologic, Epidemiologic, and Trial Data - Moderator: Scott Grundy

This session will attempt to link the evidence together in conceptual models, address how basic science and clinical/population data may be concordant or discordant, and identify gaps in knowledge.

8:30 a.m. - Linking biologic, epidemiologic, and trial data: what is the relationship of CRP to CVD? - Philip Greenland
8:50 a.m. - Biology of human C-reactive protein and cardiovascular disease – Mark Pepys
9:10 a.m. - CRP in cardiovascular disease: reflections on progress made and gaps remaining – Tom Pearson
9:30 a.m. - Break
10:00 a.m. - Discussion Panel: Philip Greenland, Mark Pepys, Paul Ridker, Thomas Pearson, Sid Smith

Session 4: Future Research Directions - Moderators: Scott Grundy and Aaron Folsom

This session will collate the research recommendations from all the previous sessions for basic, clinical, and population research, identify any cross-cutting research topics, and conclude with recommendations for priorities for future research.

10:45 a.m. - Discussion Panel: Scott Grundy, Aaron Folsom, Mark Pepys, Peter Libby – Participation by all attendees

Noon - Adjourn

Followed by a post-meeting working lunch of chairs and NHLBI Planning Committee to discuss preparation of the written recommendations.

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