Design and Rationale of the Intima-Medial Thickness Sub-Study of the PreventIon of CArdiovascular Events in iSchemic Stroke Patients with High Risk of Cerebral hemOrrhage (PICASSO-IMT) Study

Woo-Keun Seo; Yong Jae Kim; Juneyoung Lee; Sun U Kwon; PICASSO Investigators

doi:10.1016/j.jstrokecerebrovasdis.2017.06.035

Design and Rationale of the Intima-Medial Thickness Sub-Study of the PreventIon of CArdiovascular Events in iSchemic Stroke Patients with High Risk of Cerebral hemOrrhage (PICASSO-IMT) Study

J Stroke Cerebrovasc Dis. 2017 Sep;26(9):1892-1898. doi: 10.1016/j.jstrokecerebrovasdis.2017.06.035. Epub 2017 Jul 22.

Authors

Woo-Keun Seo¹, Yong Jae Kim², Juneyoung Lee³, Sun U Kwon⁴; PICASSO Investigators

Collaborators

PICASSO Investigators:
S U Kwon⁵, J Y Lee⁶, Y J Kim⁷, W K Seo⁸, S U Kwon⁵, S H Lee⁹, Y S Lee¹⁰, D E Kim¹¹, J H Lee¹², J H Rha¹³, Y J Kim⁷, K Y Park¹⁴, S H Heo¹⁵, K H Cho⁶, H Y Kim¹⁶, Y D Kim¹⁷, A H Cho¹⁸, J S Baik¹⁹, J S Lee²⁰, J Y Lee²¹, J Park²², W K Seo⁸, T H Park²³, E G Kim²⁴, I S Koh²⁵, J K Cha²⁶, N C Choi²⁷, J H Kwon²⁸, S I Sohn²⁹, J Lee³⁰, Y H Hwang³¹, H J Song³², B S Shin³³, J T Kim³⁴, S J Lee³⁵, H Y Park³⁶, S H Ahn³⁷, P W Chung³⁸, S B Kwon³⁹, J H Lee⁴⁰, D I Sin³³, J K Do⁴¹, S B Lee⁴², Y B Lee⁴³, B G Yoo⁴⁴, S M Sung⁴⁵, O Kim⁴⁶, J M Jung⁶, K Y Lee⁴⁷, Y H Jung⁴⁸

Affiliations

¹ Department of Neurology and Stroke Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
² Stroke Center and Department of Neurology, College of Medicine, Ewha Womans University, Seoul, South Korea.
³ Department of Biostatistics, College of Medicine, Korea University, Seoul, South Korea; Stroke Center and Department of Neurology, Asan Medical Center, University of Ulsan, Seoul, South Korea.
⁴ Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: sukwon@amc.seoul.kr.
⁵ Asan Medical Center, South Korea.
⁶ Korea University Anam Hospital, South Korea.
⁷ Ewaha Womans University Mokdong Hospital, South Korea.
⁸ Samsung Medical Center, Sungkyunkwan University, South Korea.
⁹ Seoul National University Hospital, South Korea.
¹⁰ Seoul National University Boramae Hospital, South Korea.
¹¹ Dongguk University Ilsan Hospital, South Korea.
¹² Kangdong Sacred Heart Hospital, South Korea.
¹³ Inha University Hospital, South Korea.
¹⁴ Chung-Ang University Hospital, South Korea.
¹⁵ Kyung Hae University Hospital, South Korea.
¹⁶ Konkuk University Medical Center, South Korea.
¹⁷ Severance Hospital, South Korea.
¹⁸ The Catholic University of Korea, St. Mary's Hospital, South Korea.
¹⁹ Inje University Sanggye Paik Hospital, South Korea.
²⁰ Ajou University Hospital, South Korea.
²¹ Yonsei University Wonju Serverance Christian Hospital, South Korea.
²² Myongji Hospital, South Korea.
²³ Seoul Medical Center, South Korea.
²⁴ Inje University Pusan Paik Hospital, South Korea.
²⁵ National Medical Center, South Korea.
²⁶ Dong-A University Medical Center, South Korea.
²⁷ Gyeongsang National University Hospital, South Korea.
²⁸ Ulsan University Hospital, South Korea.
²⁹ KeiMyung University Dongsan Medical Center, South Korea.
³⁰ Yeungnam University Hospital, South Korea.
³¹ Kyungbuk National University Hospital, South Korea.
³² Chungnam National University Hospital, South Korea.
³³ Chonbuk National University Hospital, South Korea.
³⁴ Chonnam National University Hospital, South Korea.
³⁵ Eulji University Hospital, South Korea.
³⁶ Wonkwang University Hospital, South Korea.
³⁷ Chosun University Hospital, South Korea.
³⁸ Kangbuk Samsung Hospital, South Korea.
³⁹ Kangnam Sacred Heart Hospital, South Korea.
⁴⁰ National Health Insurance Corporation Ilsan Hospital, South Korea.
⁴¹ Catholic University of Daegu, South Korea.
⁴² Daejeon St. Mary's Hospital, South Korea.
⁴³ Gachon University Gil Hospital, South Korea.
⁴⁴ Kosin University Gospel Hospital, South Korea.
⁴⁵ Pusan National University Hospital, South Korea.
⁴⁶ Bundang CHA Medical Center, South Korea.
⁴⁷ Hanyang University Guri Hospital, South Korea.
⁴⁸ Changwon Fatima Hospital, South Korea.

PMID: 28739344
DOI: 10.1016/j.jstrokecerebrovasdis.2017.06.035

Abstract

Background: Atherosclerosis is one of the main mechanisms of stroke and cardiovascular diseases and is associated with increased risk of recurrent stroke and cardiovascular events. Intima-medial thickness (IMT) is a well-known surrogate marker of atherosclerosis and has been used to predict stroke and cardiovascular events. However, the clinical significance of IMT and IMT change in stroke has not been investigated in well-designed studies. The PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage-Intima-Media Thickness (PICASSO-IMT) sub-study is designed to investigate the effects of cilostazol, probucol, or both on IMT in patients with stroke.

Methods: PICASSO-IMT is a prospective sub-study of the PICASSO study designed to measure IMT and plaque score at 1, 13, 25, 37, and 49 months after randomization.

Results: The primary outcome is the change in mean carotid IMT, which is defined as the mean of the far-wall IMTs of the right and left common carotid arteries, between baseline and 13 months after randomization.

Conclusion: PICASSO-IMT will provide the largest IMT data set in a stroke population and will provide valuable information about the clinical significance of IMT in patients with ischemic stroke.

Keywords: Intima-medial thickness; atherosclerosis; ischemic stroke; randomized clinical trial; recurrence.

Publication types

Randomized Controlled Trial

MeSH terms

Brain Ischemia / diagnostic imaging
Brain Ischemia / etiology*
Brain Ischemia / prevention & control
Cardiovascular Agents / therapeutic use
Carotid Artery Diseases / complications
Carotid Artery Diseases / diagnostic imaging*
Carotid Artery Diseases / drug therapy
Carotid Artery, Common / diagnostic imaging*
Carotid Artery, Common / drug effects
Carotid Intima-Media Thickness*
Cerebral Hemorrhage / diagnostic imaging
Cerebral Hemorrhage / etiology*
Cerebral Hemorrhage / prevention & control
Cilostazol
Clinical Protocols
Double-Blind Method
Humans
Predictive Value of Tests
Probucol / therapeutic use
Prospective Studies
Republic of Korea
Research Design
Risk Factors
Stroke / diagnostic imaging
Stroke / etiology*
Stroke / prevention & control
Tetrazoles / therapeutic use
Time Factors
Treatment Outcome

Substances

Cardiovascular Agents
Tetrazoles
Cilostazol
Probucol