Keith Norris ¹ John Salerno ^2* C. Noel Bairey Merz ³ Vidya Kaushik ⁴ Simon Geletta ⁵ Amparo Castillo ⁶ Sanford I Nidich ⁷ Carolyn Gaylord-King ² Robert Schneider ⁸

• ¹ Cardiovascular Center, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, United States
• ² Institute for Prevention Research, Fairfield, Iowa, United States
• ³ Smidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, California, United States
• ⁴ Charles R. Drew University of Medicine and Science, Los Angeles, California, United States
• ⁵ Des Moines University, Des Moines, Iowa, United States
• ⁶ Division of Community Health Sciences, School of Public Health, University of Illinois at Chicago, Chicago, Illinois, United States
• ⁷ Institute for Prevention Research, Fairfield, IA, United States
• ⁸ Center for Natural Medicine and Prevention, College of Integrative Medicine, Maharishi International University,, Fairfield, IA, United States

Introduction: Black Americans suffer from disproportionately high rates of cardiovascular disease (CVD). Psychosocial stress contributes to this disparity. Previous studies reported that the Transcendental Meditation (TM) technique reduced CVD risk factors, surrogate endpoints, and major adverse clinical events (MACE) in high-risk populations. However, no study has evaluated the effects of stress reduction with meditation on surrogate markers such as carotid intima media thickness (cIMT) along with MACE. Therefore, this RCT evaluated the effects of meditation and health education (HE) on cIMT and MACE in high-risk Black adults.: Participants were Black women and men with CVD or at high risk. They were randomized to either TM or HE. The primary outcome was change in cIMT measured by B-mode ultrasound at baseline and 12 months. The main secondary outcome was MACE at 5 years (maximum) of follow-up. Other secondary outcomes were MACE at 1 and 10 years of follow-up, blood pressure and serum lipids after one year. Exploratory variables were comparison of cIMT changes to historical controls and MACE after 14 years.Results: There were 197 randomized participants of whom 136 completed posttest for cIMT.After one year, the TM and HE groups showed average cIMT changes of -0.0004 and -0.0003 mm, respectively, with no significant difference between groups and no significant differences between groups in lipid levels or BP. However, both TM and HE groups showed prevention of progression of cIMT compared to historical controls at 12 months. In the survival analysis of MACE, there was a 65% relative risk reduction in the TM group at after 5 (maximum) years of follow up (HR= 0.346; 95% CI=0.134-0.893; p=.017). At 1 and 10 years of follow-up, there were significant risk reductions in the TM vs HE group which was not significant at 14 years (all yearly maximums).Discussion: Both treatment groups demonstrated prevention of progression of cIMT over 12 months compared to historical controls. However, the TM group showed relative risk reduction for MACE of 65% at 5 years. Therefore, as a lifestyle modification method, TM may be useful in the secondary prevention of CVD in this and possibly other high-risk groups.