Registries - IMACS Registry > Protocol/Appendices



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In December 2015, the following revision was made in the protocol in regards to retrospective data,

3.3 Prospective Design

Previous Text: “IMACS is primarily a prospective registry that will collect clinical data, including follow up, essentially as it happens. Post implant follow up data will be collected at 1 week, 1 month, 3 months, 6 months and every 6 months after that. Major outcomes after implant, e.g. death, explant, rehospitalization and adverse events, will be entered as they occur and also as part of the defined follow-up intervals.”

Current Text: “IMACS is primarily a prospective registry that will collect clinical data, including follow up, essentially as it happens.

There are a few guidelines that apply to retrospective data entry that all participants must abide by and they are as follows:
  • The IMACS Registry Web Based Data Entry system (WBDE) will only accept retrospective data on or after January 1, 2011.
  • The site understands that annual reports and most scientific reports produced using IMACS data will only use prospective data in its analyses.
  • Post implant follow up data will be collected at 1 month, 3 months, 6 months and every 6 months after that. Major outcomes after implant, e.g. death, explant, and adverse events, will be entered as they occur and also as part of the defined follow-up intervals.”
The above information will be incorporated into the next version of the protocol if amended.

NOTE TO SITES: Please attach a hardcopy of THIS LETTER (PDF) to the IMACS Protocol Version 1.0, Version Date 12/21/12 hardcopy and submit it to your Ethics Committee/Regulatory Board for review and approval.


The IMACS Protocol Version 1.0 (PDF) contains guidelines and information regarding the IMACS Registry. Some of the topics located in the protocol are as follows:
  • IMACS Purpose and Structure
  • Patient Eligibility
  • Site Eligibility and Enrollment
  • Patient Safety
  • Data Collection
  • Analyses of Registry Data
  • Periodic Statistical Summaries
  • Quality Assurance
  • Hospitals: Requirements, Training, Assistance and Audits
  • Collectives

Appendix A - Policies and Standard Operating Procedures



Appendix B - Memorandum of Agreement - Hospital

Participating sites / collectives must complete the Appendix B: ISHLT Memorandum of Agreement - Hospital (PDF) prior to enrollment. The signed agreement should be forwarded to IMACS® Representative at imacs@uabmc.edu.


Appendix C - Memorandum of Agreement - Collective

Participating sites / collectives must complete the Appendix C: ISHLT Memorandum of Agreement - Collective (PDF) prior to enrollment. The signed agreement should be forwarded to IMACS® Representative at imacs@uabmc.edu.


Appendix D – Adverse Event Definitions

IMACS collects data on the following adverse events:
  • Device Malfunction
  • Infection
  • Neurological Dysfunction
  • Bleeding
  • Respiratory Failure
    Arterial Non-CNS Thromboembolism
  • Right Heart Failure
For definitions of the adverse events, see Appendix D: Adverse Event Definitions (PDF).


Appendix E - Regulatory Guidelines

For guidelines to assist with enrolling your institution or collective with IMACS, see Appendix E: Regulatory Guidelines (PDF).


REFERENCES

ISHLT Mechanically Assisted Circulatory Support Registry Protocol. (2012). Birmingham, AL

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