Study Type
Interventional - Drug
completed
-
The objective of the RECREATE pilot study was to evaluate the hypothesis that insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia and result in reduction in cardiovascular events.
(The pilot was not powered to provide conclusive results on effects of insulin on clinical events. If safe and associated with glucose lowering a full scale trial was planned.)
Primary endpoint:
The 24-hour difference in mean glucose between the two study groups.
Secondary endpoints: The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first); Tthe difference in mean glucose level achieved at 30 days between study groups; nonfatal recurrent myocardial infarction; nonfatal stroke; cardiovascular death (as a composite and as separate outcomes); rehospitalization for congestive heart failure; all-cause mortality; resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes); cardiogenic shock; cardiac procedures; rehospitalization for any cause; symptomatic and severe hypoglycemic episodes; hypokalemic episodes.
All clinical event endpoints were adjudicated.
Study Design
Randomized, open label, placebo control, parallel group
NO. of Countries
3
NO. of Sites
17
NO. of Participants
287
Study Period
2008-2010
Sponsor
PHRI
Hertzel Gerstein
Interim Executive Director; Senior Scientist
Hertzel Gerstein
Interim Executive Director; Senior Scientist
Hertzel Gerstein is PHRI’s Interim Executive Director and Senior Lead of the Diabetes Scientific Program. He is also a Professor of Medicine at McMaster University where he holds the Population Health Research Institute Chair in Diabetes; an Endocrinologist; Director of the Boris Clinic Diabetes Care and Research Program; Chair of Diabetes Clinical Trials Network Canada; and a Fellow of both the Canadian Academy of Health Sciences and the Royal Society of Canada.
Gerstein pioneered and firmly established international long-term diabetes-focused outcomes trials as the norm to support Evidence-Based Diabetes Care. Randomized trials that he designed and led have collectively included more than 90,000 people with either diabetes or prediabetes to date, and have studied and identified clinically important, life-saving diabetes therapies. These trials were supported by the US National Institute of Health, the Canadian Institutes of Health Research, other Canadian peer-review agencies, and by industry. Together, they have substantially expanded the evidence-base pertaining to the prevention, remission, and treatment of diabetes and its consequences, and some of their findings have provided the evidence base for international diabetes guidelines and novel drug indications that have improved the lives of people living with diabetes or prediabetes.
His research has been published in over 600 papers and his h index is 100. His work has been recognized by many awards, including the 2012 Canadian Diabetes Association’s Lifetime Achievement Award and the 2022 American Diabetes Association’s Outstanding Achievement in Clinical Diabetes Research Award.
Jackie Bosch
Scientist
Jackie Bosch
Scientist
Jackie Bosch is the Assistant Dean of the McMaster Occupational Therapy Program and a PHRI Scientist. She has a Bachelor’s degree in Occupational Therapy, a Master’s degree in Clinical Epidemiology and Biostatistics, and a PhD in Rehabilitation Science. She also serves as a Professor in the School of Rehabilitation and has an Adjunct Appointment with the University of Galway College of Medicine, Nursing, and Health Sciences.
Her research focuses on improving functional outcomes in clinical trials, particularly for stroke survivors in low-resource settings, and enhancing clinical trial methods. Bosch has taken on leadership roles in large-scale trials such as HOPE, HOPE-TOO, HOPE-3 (NCT00468923), DREAM (NCT00095654), ORIGIN (NCT00069784), TIPS-3 (NCT01646437), and COMPASS (NCT01776424). She leads the Organized Stroke Care Across Income Levels (OSCAIL) group, which has conducted a proof-of-concept study implementing key aspects of stroke unit care in hospitals within low-resource settings. Currently, the OSCAIL group is working on a community-based study aimed at improving outcomes for stroke survivors in these challenging environments. Bosch is also interested in optimizing how clinical trials are conducted, especially by finding new ways to make the start-up and execution processes more efficient.
Jackie Bosch has published 184 articles and received several awards, including the Lorna Reimer Award for Leadership from the Canadian Occupational Therapy Foundation in 2019 and the Faculty of Health Sciences, McMaster University, Programs Award for Graduate Students in 2014.
