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INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure (INVESTED) Data Coordinating Center (1 U01 HL130204 02/15/2016-01/31/2021)
The INVESTED trial is an NHLBI-funded study designed to determine which of two formulations of influenza vaccine – the standard dose quadrivalent influenza vaccination or an investigational higher dose trivalent influenza vaccination – is more effective in reducing deaths and cardiopulmonary hospitalizations in individuals over 18 years of age with at least one heart disease risk factor as well as a history of heart attack (within the past year) or hospitalization for heart failure (within the past 2 years).
| Principal Investigator DCC: | KyungMann Kim, PhD, University of Wisconsin-Madison |
| Co-Principal Investigators CCC: | Scott Solomon, MD, Brigham & Women’s Hospital Orly Vardeny, PharmD, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT02787044 |
| Target Enrollment: | 9,300 |
| Study Start Date: | August 2016 |
| Estimated Completion Date: | February 2021 |
| Estimated Primary Completion Date: | August 2020 (Final data collection date for primary outcome measure) |
The INVESTED Data Coordinating Center (DCC) led by Professor Kim (DCC PI) in the UW Department of Biostatistics and Medical Informatics provides expertise and support for the INVESTED trial in data management, quality control and quality assurance, information technology for communication and trial conduct monitoring, and statistical methods for design including randomization, interim monitoring, analysis both interim and final, interpretation of findings from analysis, preparation of results in tabular and graphical formats for presentation, and publication of findings from the trial. Professor Kim oversees all DCC activities with specific responsibilities for communication and trial conduct monitoring and statistical methods; UW has partnered with the Frontier Science Foundation (https://www.frontierscience.org) for data management, quality control and quality assurance, and IT support for the INVESTED trial.
The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial (MyHEART) (1 R01 HL132148 05/01/17-04/30/22)
The MyHEART trial will test the effect of the MyHEART (My Hypertension Education and Reaching Target) program, a hypertension self-management intervention consisting of home blood pressure monitoring and health coaching on hypertension control and hypertension self-management behavior as compared to usual clinical care in lowering systolic and diastolic blood pressure and to examine whether MyHEART’s effects are mediated through perceived competence, autonomy, motivation and activation in young adults with uncontrolled hypertension in a randomized, multi-center, controlled trial.
| Principal Investigator: | Kara Hoppe, DO, University of Wisconsin-Madison |
| Co-Investigator, DCC Director: | KyungMann Kim, PhD, University of Wisconsin-Madison |
| Co-Investigator: | Heather Johnson, MD, MMM, FAHA, FACC, Boca Raton Regional Hospital |
| ClinicalTrials.gov Identifier: | NCT03158051 |
| Target Enrollment: | 310 |
| Study Start Date: | February 2018 |
| Estimated Completion Date: | April 2022 |
| Estimated Primary Completion Date: | October 2021 (Final data collection date for primary outcome measure) |
The MyHEART Data Coordinating Center (DCC) will be led by Professor Kim. He will provide expertise and support for the MyHEART trial with limited involvement in data management which will be done using REDCap, a research electronic data capture system.
Fecal Microbiota Transplant for C. difficile Infection in Solid Organ Transplant Recipients (FMT) (1 U01 AI125053 09/15/18-08/31/23)
The FMT trial will test a novel intervention, fecal microbiota transplant, for treatment of C. difficile infection (CDI) in solid organ transplant recipients as compared to the standard of care oral vancomycin in reducing recurrence of CDI in a randomized, multi-center, double-blind, double-dummy controlled trial.
| Principal Investigator DCC: | Nasia Safdar, MD, University of Wisconsin-Madison |
| Co-Investigator, DCC Director: | KyungMann Kim, PhD, University of Wisconsin-Madison |
| ClinicalTrials.gov Identifier: | NCT03617445 |
| Target Enrollment: | 158 |
| Study Start Date: | February 2019 |
| Estimated Completion Date: | December 2023 |
| Estimated Primary Completion Date: | December 2023 (Final data collection date for primary outcome measure) |
The FMT Data Coordinating Center (DCC) will be led by Professor Kim. He will provide expertise and support for the FMT trial much as in the INVESTED trial in partnership with the Frontier Science Foundation for data management, quality control and quality assurance, and IT support.
Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC) (1 U24 CA242637-01 9/20/2019-7/31/2024)
The goal of the Cancer Prevention Clinical Trials Network (CP-CTNet) is to identify safe and effective preventive agents and interventions in order to advance their further clinical development for cancer prevention. The CP-CTNet Sites will perform these early phase trials supported by the NCI’s Division of Cancer Prevention and the CP-CTNet Data Management, Auditing, and Coordinating Center (DMACC). These trials include phase 0 (micro-dosing), phase I (dose-finding), and phase II (preliminary efficacy) clinical trials. To support these early phase trials to be conducted by the CP-CTNet sites alone or as cross-Network trials, the CP-CTNet DMACC will coordinate trans-Network activities and provide expertise and resources in 1) centralized data management and reporting, 2) clinical trials auditing, and 3) administrative and logistical coordination, including expertise in clinical trials methodology and biostatistics, across CP-CTNet in partnership with the Frontier Science Foundation in Amherst, NY. In addition, the CP-CTNet DMACC will provide an advisory role in early phase cancer prevention trial development for all CP-CTNet trials and the primary statistical role for cross-Network trials.
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Contact Us
KyungMann Kim, PhD
DCC Principal Investigator
kyungmann.kim@wisc.edu
608-265-6380
Kelly Miller, BS, CCRC
DCC Research Administrator
kamiller@biostat.wisc.edu
608-262-8141