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What is residual Risk
R3i Studies
Realist

The initial R3i research program involves two worldwide epidemiological studies which aim to quantify the full extent of residual macro- and microvascular risk associated with atherogenic dyslipidemia in patients with coronary heart disease (CHD) and/or type 2 diabetes receiving current standards of care.

Additionally, this research will generate hypotheses about the role of the major components of atherogenic dyslipidemia, namely elevated serum triglycerides (TG) and decreased levels of atheroprotective high-density lipoprotein cholesterol (HDL-C), and how best to intervene on these factors in the future management of cardiovascular (CV) residual risk.

Those two studies are led by Professor Frank Sacks

General objectives
  • To establish the magnitude of dyslipidemia defined by low HDL-C, high TG or both
    • In patients presenting with an acute coronary event
    • In patients with type 2 diabetes presenting with a microvascular complication
      • In patients at goal for LDL-C treated or not with a lipid lowering agent (LLA)
  • To assess the relative risk of developing
    • A coronary event associated with components of atherogenic dyslipidemia
    • A microvascular complication associated with components of atherogenic dyslipidemia in type 2 diabetes patients
      • After adjustment for other established risk factors for cardiovascular disease or microangiopathy
      • In patients at goal for LDL-C treated or not with a LLA
A unique research program
  • Individualizing the macro- and the microvascular residual risks

  • On a global geographical scale
    • Involving a large number of countries across the world
    • Allowing for possible regional subanalyses: america, europe, near end middle east, australia and asia.
  • R3i Realist Study Map
  • Conducted by the Harvard Medical School for the R3i.
An academic location and management
  • The study will be conducted by the Harvard Medical School for the R3i.
    • Project direction: Professor F. Sacks

  • Coordinating Center: Channing Laboratory, Brigham & Women’s Hospital, and Harvard Medical School
    • Data Center Director: Vincent Carey, Ph.D, Associate Professor of Biostatistics
MACROvascular
Residual Risk epidemiological study
Project Leader: Frank Sacks
Objectives
  • To determine, in patients at goal for LDL-C, treated or not for elevated LDL-C with a LLA and with a first acute CHD event :
  • - The prevalence of low plasma levels of HDL-C and/or elevated plasma TG levels
  • - Whether low HDL-C and/or elevated TG levels are associated with a significant risk of incident CHD event
Study design
  • Retrospective case-controlled study based on chart review
Current number of centers involved worldwide: 24
MACROvascular
Residual Risk epidemiological study
Project Leader: Frank Sacks
Objectives
  • To determine, in diabetic patients at goal for LDL-C, treated or not with a LLA, and with at least one microvascular diabetes-related complication:
  • - The prevalence of low plasma levels of HDL-C and/or elevated plasma TG levels
  • - Whether low HDL-C and/or elevated TG levels are associated with a significant residual risk of incident diabetes-related microvascular complications after adjustment for established risk factors for microangiopathy.
Study design
  • Retrospective case-controlled study based on chart review
Current number of centers involved worldwide: 21