INSTRuCT: Protocol, Infrastructure, and Governance. Issue 10 (25th June 2021)
- Record Type:
- Journal Article
- Title:
- INSTRuCT: Protocol, Infrastructure, and Governance. Issue 10 (25th June 2021)
- Main Title:
- INSTRuCT
- Authors:
- Pandian, Jeyaraj Durai
Verma, Shweta Jain
Arora, Deepti
Sharma, Meenakshi
Dhaliwal, Rupinder
Khatter, Himani
Huilgol, Rahul
Sylaja, P.N.
Dhasan, Aneesh
Renjith, Vishnu
Pathak, Abhishek
Pai, Aparna
Sharma, Arvind
Vaishnav, Anand
Ray, Biman
Khurana, Dheeraj
Mittal, Gaurav
Kulkarni, Girish
Sebastian, Ivy
Roy, Jayanta
Kumaravelu, Somasundaram
John, Lydia
Kate, Mahesh
Srivastava, M.V.
Kempegowda, Madhusudhan Byadarahalli
Borah, Nomal
Ramrakhiani, Neetu
Rai, Nirendra
Ojha, Pawan
Bhatia, Rohit
Das, Rupjyoti
Sureshbabu, Sachin
Jabeen, Shaikh Afshan
Bhoi, Sanjeev
Aaron, Sanjith
Sarma, Prabhakaran
Saroja, Aralikatte Onkarappa
Abraham, Sherly
Sharma, Sudhir
Sulena, Sulena
Gorthi, Sankar
Nagarjunakonda, Sundarachary
Narayan, Sunil
Mathew, Thomas
George, Tina
Vijaya, Pamidimukkala
Huded, Vikram
Nambiar, Vivek
Reddy, Y. Muralidhar
… (more) - Abstract:
- Abstract : Supplemental Digital Content is available in the text. Abstract : Background and Purpose: Very few large scale multicentric stroke clinical trials have been done in India. The Indian Council of Medical Research funded INSTRuCT (Indian Stroke Clinical Trial Network) as a task force project with the objectives to establish a state-of-the-art stroke clinical trial network and to conduct pharmacological and nonpharmacological stroke clinical trials relevant to the nation and globally. The purpose of the article is to enumerate the structure of multicentric stroke network, with emphasis on its scope, challenges and expectations in India. Methods: Multiple expert group meetings were conducted by Indian Council of Medical Research to understand the scope of network to perform stroke clinical trials in the country. Established stroke centers with annual volume of 200 patients with stroke with prior experience of conducting clinical trials were included. Central coordinating center, standard operating procedures, data and safety monitoring board were formed. Discussion: In first phase, 2 trials were initiated namely, SPRINT (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India) and Ayurveda treatment in the rehabilitation of patients with ischemic stroke in India (RESTORE [Rehabilitation of Ischemic stroke Patients in India: A Randomized controlled trial]). In second phase, 4 trials have been approved. SPRINT trial was the first to beAbstract : Supplemental Digital Content is available in the text. Abstract : Background and Purpose: Very few large scale multicentric stroke clinical trials have been done in India. The Indian Council of Medical Research funded INSTRuCT (Indian Stroke Clinical Trial Network) as a task force project with the objectives to establish a state-of-the-art stroke clinical trial network and to conduct pharmacological and nonpharmacological stroke clinical trials relevant to the nation and globally. The purpose of the article is to enumerate the structure of multicentric stroke network, with emphasis on its scope, challenges and expectations in India. Methods: Multiple expert group meetings were conducted by Indian Council of Medical Research to understand the scope of network to perform stroke clinical trials in the country. Established stroke centers with annual volume of 200 patients with stroke with prior experience of conducting clinical trials were included. Central coordinating center, standard operating procedures, data and safety monitoring board were formed. Discussion: In first phase, 2 trials were initiated namely, SPRINT (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India) and Ayurveda treatment in the rehabilitation of patients with ischemic stroke in India (RESTORE [Rehabilitation of Ischemic stroke Patients in India: A Randomized controlled trial]). In second phase, 4 trials have been approved. SPRINT trial was the first to be initiated. SPRINT trial randomized first patient on April 28, 2018; recruited 3048 patients with an average of 128.5 per month so far. The first follow-up was completed on May 27, 2019. RESTORE trial randomized first patient on May 22, 2019; recruited 49 patients with an average of 3.7 per month so far. The first follow-up was completed on August 30, 2019. Conclusions: In next 5 years, INSTRuCT will be able to complete high-quality large scale stroke trials which are relevant globally. REGISTRATION: URL: http://www.ctri.nic.in/ ; Unique Identifier: CTRI/2017/05/008507. … (more)
- Is Part Of:
- Stroke. Volume 52:Issue 10(2021)
- Journal:
- Stroke
- Issue:
- Volume 52:Issue 10(2021)
- Issue Display:
- Volume 52, Issue 10 (2021)
- Year:
- 2021
- Volume:
- 52
- Issue:
- 10
- Issue Sort Value:
- 2021-0052-0010-0000
- Page Start:
- e574
- Page End:
- e580
- Publication Date:
- 2021-06-25
- Subjects:
- incidence -- ischemic stroke -- network -- research -- secondary prevention -- stroke trials -- technology
Cerebrovascular disease -- Periodicals
Cerebral circulation -- Periodicals
616.81 - Journal URLs:
- http://ovidsp.tx.ovid.com/sp-3.16.0b/ovidweb.cgi?&S=GJCMFPNHCPDDNANKNCKKCFFBNGMHAA00&Browse=Toc+Children%7cYES%7cS.sh.15204_1441956414_76.15204_1441956414_88.15204_1441956414_96%7c411%7c50 ↗
http://www.stroke.ahajournals.org/ ↗
http://stroke.ahajournals.org/ ↗
http://journals.lww.com ↗
http://www.lww.com/Product/0039-2499 ↗ - DOI:
- 10.1161/STROKEAHA.120.033149 ↗
- Languages:
- English
- ISSNs:
- 0039-2499
- Deposit Type:
- Legaldeposit
- View Content:
- Available online (eLD content is only available in our Reading Rooms) ↗
- Physical Locations:
- British Library DSC - 8474.900000
British Library DSC - BLDSS-3PM
British Library HMNTS - ELD Digital store - Ingest File:
- 19792.xml