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Pandian JD, Verma SJ, Arora D, et al. INSTRuCT: Protocol, Infrastructure, and Governance. Stroke. 2021;52(10):e574-e580doi: 10.1161/STROKEAHA.120.033149.
Pandian, J. D., Verma, S. J., Arora, D., Sharma, M., Dhaliwal, R., Khatter, H., Huilgol, R., Sylaja, P. N., Dhasan, A., Renjith, V., Pathak, A., Pai, A., Sharma, A., Vaishnav, A., Ray, B., Khurana, D., Mittal, G., Kulkarni, G., Sebastian, I., Roy, J., Kumaravelu, S., John, L., Kate, M., Srivastava, M. V., Kempegowda, M. B., Borah, N., Ramrakhiani, N., Rai, N., Ojha, P., Bhatia, R., Das, R., Sureshbabu, S., Jabeen, S. A., Bhoi, S., Aaron, S., Sarma, P., Saroja, A. O., Abraham, S., Sharma, S., Sulena, S., Gorthi, S., Nagarjunakonda, S., Narayan, S., Mathew, T., George, T., Vijaya, P., Huded, V., Nambiar, V., & Reddy, Y. M. (2021). INSTRuCT: Protocol, Infrastructure, and Governance. Stroke, 52(10), e574-e580. https://doi.org/10.1161/STROKEAHA.120.033149
Pandian, Jeyaraj Durai, et al. "INSTRuCT: Protocol, Infrastructure, and Governance." Stroke vol. 52,10 (2021): e574-e580. doi: https://doi.org/10.1161/STROKEAHA.120.033149
Pandian JD, Verma SJ, Arora D, Sharma M, Dhaliwal R, Khatter H, Huilgol R, Sylaja PN, Dhasan A, Renjith V, Pathak A, Pai A, Sharma A, Vaishnav A, Ray B, Khurana D, Mittal G, Kulkarni G, Sebastian I, Roy J, Kumaravelu S, John L, Kate M, Srivastava MV, Kempegowda MB, Borah N, Ramrakhiani N, Rai N, Ojha P, Bhatia R, Das R, Sureshbabu S, Jabeen SA, Bhoi S, Aaron S, Sarma P, Saroja AO, Abraham S, Sharma S, Sulena S, Gorthi S, Nagarjunakonda S, Narayan S, Mathew T, George T, Vijaya P, Huded V, Nambiar V, Reddy YM. INSTRuCT: Protocol, Infrastructure, and Governance. Stroke. 2021 Oct;52(10):e574-e580. doi: 10.1161/STROKEAHA.120.033149. Epub 2021 Jun 25. PMID: 34167324.
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Stroke. 2021 Oct;52(10):e574-e580. doi: 10.1161/STROKEAHA.120.033149. Epub 2021 Jun 25.

INSTRuCT: Protocol, Infrastructure, and Governance.

Stroke

Jeyaraj Durai Pandian, Shweta Jain Verma, Deepti Arora, Meenakshi Sharma, Rupinder Dhaliwal, Himani Khatter, Rahul Huilgol, P N Sylaja, Aneesh Dhasan, Vishnu Renjith, Abhishek Pathak, Aparna Pai, Arvind Sharma, Anand Vaishnav, Biman Ray, Dheeraj Khurana, Gaurav Mittal, Girish Kulkarni, Ivy Sebastian, Jayanta Roy, Somasundaram Kumaravelu, Lydia John, Mahesh Kate, M V Srivastava, Madhusudhan Byadarahalli Kempegowda, Nomal Borah, Neetu Ramrakhiani, Nirendra Rai, Pawan Ojha, Rohit Bhatia, Rupjyoti Das, Sachin Sureshbabu, Shaikh Afshan Jabeen, Sanjeev Bhoi, Sanjith Aaron, Prabhakaran Sarma, Aralikatte Onkarappa Saroja, Sherly Abraham, Sudhir Sharma, Sulena Sulena, Sankar Gorthi, Sundarachary Nagarjunakonda, Sunil Narayan, Thomas Mathew, Tina George, Pamidimukkala Vijaya, Vikram Huded, Vivek Nambiar, Y Muralidhar Reddy

Affiliations

  1. Department of Neurology (J.D.P., S.J.V., D.A., H.K., R.H., M.K.), Christian Medical College, Ludhiana, Punjab, India.
  2. Non-Communicable Diseases Section, Indian Council of Medical Research, New Delhi, India (M.S., R. Dhaliwal).
  3. Department of Neurology (P.N.S., A.D., V.R.), Sri Chitra Tirunal Institute of Medical Sciences and Technology, Thiruvananthapuram, Kerala, India.
  4. Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India (A. Pathak).
  5. Department of Neurology, Kasturba Medical College and Hospital, Manipal, Karnataka, India (A. Pai, S.G.).
  6. Department of Neurology, Zydus Hospital, Ahmedabad, Gujarat, India (A.S.).
  7. Vadodara Institute of Neurosciences, Vadodara, Gujarat, India (A.V.).
  8. Bangur Institute of Neurosciences, Kolkata, India (B.R.).
  9. Department of Neurology, Post Graduate Institute of Medical Education and Research, Chandigarh, India (D.K.).
  10. Department of Neurology, St Stephens Hospital, Delhi, India (G.M., I.S., S. Sureshbabu).
  11. Department of Neurology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India (G.K.).
  12. Department of Neurology, Institute of Neurosciences, Kolkata, West Bengal, India (J.R.).
  13. Department of Neurology, Ramesh Hospital, Guntur, Andhra Pradesh, India (S.K.).
  14. Department of Medicine, Baptist Christian Hospital, Tezpur, Assam, India (L.J., S. Abraham).
  15. Department of Neurology, All India Institute of Medical Sciences, New Delhi, India (M.V.S., R.B.).
  16. Department of Neurology, BGS Global Hospital, Bangalore, Karnataka, India (M.B.K.).
  17. Department of Neurology, Guwahati Neurological Research Centre, Dispur, India (N.B., R. Das).
  18. Department of Neurology, Fortis Escorts Hospital, Jaipur, Rajasthan, India (N. Ramrakhiani).
  19. Department of Neurology, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India (N. Rai).
  20. Department of Neurology, Grant Government Medical College and Sir J.J. Group of Hospitals College, Mumbai, India (P.O.).
  21. Department of Neurology, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India (S.A.J.).
  22. Department of Neurology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India (S.B.).
  23. Department of Neurology, Christian Medical College, Vellore, Tamil Nadu, India (S. Aaron, T.G.).
  24. Achutha Menon Center for Health Science Studies (P.S.), Sri Chitra Tirunal Institute of Medical Sciences and Technology, Thiruvananthapuram, Kerala, India.
  25. Department of Neurology, KLE Academy of Higher Education & Research, Belagavi, Karnataka, India (A.O.S.).
  26. Department of Neurology, Indira Gandhi Medical College & Hospital, Shimla, Himachal Pradesh, India (S. Sharma).
  27. Department of Neurology, GGS Medical College, Faridkot, Punjab, India (S. Sulena).
  28. Department of Neurology, Government General Hospital, Guntur, Andhra Pradesh, India (S. Nagarjunakonda).
  29. Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India (S. Narayan).
  30. Department of Neurology, St John's Medical College, Bangalore, Karnataka, India (T.M.).
  31. Department of Neurology, Lalitha Super Speciality Hospital, Guntur, Andhra Pradesh, India (P.V.).
  32. Department of Neurology, Mazumdar Shaw Medical Centre, Narayana Hrudayalaya, Bangalore, Karnataka, India (V.H.).
  33. Department of Neurology, Amrita Institute of Medical Sciences, Kochi, Kerala, India (V.N.).
  34. Department of Neurology, CARE Hospital, Hyderabad, Telangana, India (M.R.).

PMID: 34167324 DOI: 10.1161/STROKEAHA.120.033149

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.

Keywords: incidence; ischemic stroke; network; research; secondary prevention; stroke trials; technology

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