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General Forms Training

General Forms Training. RESCUE R andomized E valuation of Patients with S table Angina C omparing U tilization of Diagnostic E xaminations A Phase III, Multicenter, Randomized, Controlled, Comparative-Effectiveness Trial. ACRIN RESCUE Data Management Forms Training. Kimberly Brown, RA

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General Forms Training

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  1. General Forms Training RESCUE Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations A Phase III, Multicenter, Randomized, Controlled, Comparative-Effectiveness Trial

  2. ACRIN RESCUE Data Management Forms Training Kimberly Brown, RA Roberta Clune RA Bola Shodunke , RA Victoria Shoyelu, RA

  3. Training Overview • Main Goals/Aims of Study • Purpose of Study • Case Report Forms • Good Clinical Practices

  4. 4701 Main Goals/Aims The main goals/aims of the study are: • To compare outcomes from two different ways to diagnose the cause of your chest pain using: • Nuclear medicine cardiac stress test (standard diagnostic imaging test also known as SPECT MPI) • Coronary Computed Tomography Angiography (CCTA also known as Cardiac CT) • To see if medication prescribed based on the imaging results can safely prevent or delay the need for an invasive procedure for your heart disease

  5. Purpose of Study • This study will compare outcomes in patients with stable angina who are randomized to one of two imaging tests for diagnosis-CCTA or nuclear medicine cardiac stress testing (SPECT MPI) • Estimated costs associated with cardiac-related healthcare after diagnosis using CCTA or SPECT MPI will be compared to determine the cost-effectiveness of each approach • Quality-of-life tools will be administered to participants to assess differences in well being between the two diagnostic groups • The diagnostic results will be evaluated to try to create better ways to predict revascularization, heart attack, or death and therefore to guide treatment after CCTA results

  6. Data Collection Case Report Forms

  7. Online Data Management System: Navigating the ACRIN Websitehttp://www.acrin.org

  8. ACRIN .org Access to all RESCUE study related Documents (paper CRFs) Click RESCUE Field or Protocol Summary Table

  9. Access 4701 protocol here

  10. Access the paper data forms here

  11. Form Index • The Form Index provides an outline of required forms at each visit and additional forms available if needed • Pleases refer to the index for current form version #’s and version dates

  12. Completion Instructions • The General and Form Specific Completion Instructions are available on the 4701 Data Forms website

  13. Coordinators Worksheet for Eligibility • This worksheet is to aid in determining eligibility.

  14. Coordinators Worksheet for Eligibility

  15. AO Form (1 of 3) There are two A0 data forms, one used with the initial protocol and the 2nd one with amendment 1, dated May 4, 2011 The A0 Form is required to register each participant in the study At the time of enrollment, the participant must review, sign, and date the consent

  16. A0 Form (2 of 2) • Complete Inclusion and Exclusion Parts 2 and 3 prior to registration to determine and confirm study eligibility • Submit the A0 form via the ACRIN data center at www.acrin.org within 24 hours of completion

  17. AO Form (3 of 3) Protocol section 7.0 describes Registration and Randomization procedures • Please contact ACRIN data management for manual study registration, in the event that the website is down. Initials of person completing the form: Initials of person(s) responsible for reviewing the data and completing form. • This may be different than the person web entering the form. • Web entry is tracked electronically through the entry of the username and password.

  18. 5.2 Exclusion criteria • 5.2.9 History of known left ventricular ejection fraction < 45%: • A0 Q39 - Answer should be No to meet eligibility • If the most recent Hx of LVEF is <45%, the answer to A0 Q39 could be Yes. However, the site is allowed to perform another LVEF prior to registering the patient. • If the new LVEF is > 45%, the patient is eligible and randomized. A0 Q39 = No. • If the LVEF is still < 45%, the patient is ineligible and not randomized. A0 Q39 = Yes. • 2. If the most recent Hx of LVEF is < 45%, and no LVEF is repeated prior to registration, the answer to A0 Q39 is Yes. The patient is ineligible and not randomized. • 3. If the most recent Hx of LVEF is > 45%, and no LVEF is repeated prior to registration, the answer to A0 Q39 is No. The patient is eligible and randomized.

  19. ACRIN Informed Consent Page 1 of 2

  20. ACRIN Informed Consent Page 2 of 2Please note the very last line on page 5 of the consent:“ Your medical records will continue to be collected until the end of the study unless you withdraw your authorization in writing, as described in the separate authorization to release medical records.”

  21. Participant Contact Information Sheet (1 of 2) • Completed by participants at time of consent which provides contact information for use in the 12 month QOL sub-study • Foreign sites are not participating in the QOL sub-study, therefore this form will be maintained at the site • VA sites will use as a worksheet and maintain at the site • US domestic sites must fax form upon registration to both: • 1) ACRIN Data Management (215-940-8922) to allow identification for medical chart procurement requests. • 2) Brown University (401-863-9635) for use in the QOL sub-study at 12 months

  22. Authorization to Release/Disclose Medical Records Template (1 of 2) • Provides ACRIN authorization for medical chart procurement. • Completed by participants at consent • Foreign sites and VA sites do not submit to ACRIN and should maintain on site only • US domestic sites must fax form upon registration to ACRIN Data Management (215-940-8922)

  23. Authorization to Release/Disclose Medical Records Template (2 of 2) Letter d specifically states that revocation of the authorization must be in writing to the site and given to ACRIN.

  24. EK-EKG/Biomarker Form (1 of 2) • EKG’s performed within 30 days prior to diagnostic imaging are acceptable • If not performed, unavailable, or not completed within the 30 days, a new ECG should be completed at the time of diagnostic imaging (e.g., in the case of ECG during SPECT MPI); • All participants are to have a 12 lead EKG on file at ACRIN • Originals preferred but color photocopies are sufficient • Mail in de-identified EKG with case label to: • ACRIN 4701 RESCUE • Core Lab • 1818 Market Street Suite 1700 • Philadelphia, Pa 19103-3609 • All clinical biomarkers must be reported if drawn within the previous 28 days of enrollment

  25. EK-EKG/Biomarker Form (2 of 2)

  26. CR Cardiac Risk Form • Access cardiac risk and co-morbidity criteria for patients with stable angina • Gray areas indicate questions that the RA are to ask the participants • White areas are to be obtained from the patient/medical record by the RA • Please refer to the form specific CRF instructions when completing this form

  27. Diagnostic Imaging – the beginnings of the Adjudication process CCTA and SPECT/MPI Reader Forms must be completed by an ACRIN qualified Radiologist, Cardiologist or their designated Research Staff. In unique circumstances where the CCTA and SPECT MPI Reader Forms are not completed by an ACRIN qualified Radiologist, Cardiologist, etc., a PR form is required.

  28. CCTA Reader Form (1 of2) The purpose of this form is to collect clinical, diagnostic and radiological data that occurs with CCTA Imaging (Group A). Positive cardiac findings on the CCTA are defined as: ≥ 50% stenosis on CCTA OR Un-evaluable left main, or proximal and mid segments of all other epicardial arteries (right coronary artery, left anterior descending artery, or left circumflex artery) Tip:Follow-up for a MACE event at the 2 week and 2 month timepoint will be required when there is a > 50% stenosis in any of the vessel segments, e.g. obtuse marginal

  29. CCTA Reader Form (2 of 2) Question #7: Incidental Findings on the CT are any other findings found on the contrast or non-contrast runs of the Coronary CT angiograms scans. Questions #9 and #10 Reference the Schema to determine the treatment arm for >50% stenosis vessel Question # 11 Any other stenosis noted less than 50% will be treated according per institution standard of care and None is an appropriate choice .

  30. CT Reader FormSummary • If Research Staff have questions or discrepancies regarding the CCTA data, they are to seek the guidance of the reader who interpreted the participant’s CCTA before submission to ACRIN. • Incidental Findings on the CT are any other findings found on the contrast or non-contrast runs of the Coronary CT angiograms scans. • If any LM (left main) disease of > 50% is seen on CT, participant should go to ICA (cardiac catheterization) per protocol. • If any other vessel other than the LM is determined > 50% in diameter, participant should go to OMT (optimal medical therapy) per protocol. • If any proximal or mid cardiac vessel segments are indeterminate, participant should go to OMT. • Any other stenosis noted less than 50% will be treated according per institution standard of care and None would be an appropriate choice for this scenario. (Q11)

  31. TC- CCTA Technical Assessment Form • Completed within two weeks of consent for participants who undergo contrast-enhanced CCTA (Coronary Computed Tomography Angiography) following randomization to Group A for the evaluation of suspected CAD (Coronary Artery Disease) • This form’s main purpose is to record whether or not the scan was completed, scanner details, contrast and medications given • A CCTA is done in 2 phases- the non-contrast ‘run’ and the contrast ‘run’. The non-contrast run is done first before the injection of the contrast. This captures the heart calcium score. Often if calcium scores are too high, the CCTA will not be completed with the contrast run. The non-contrast run will also detect incidental findings in other anatomical areas • If AE’s were present, the AE form should be completed

  32. SP- SPECT MPI Reader Form (1 of 2) • The purpose of this form is to collect clinical, diagnostic and radiological data that occurs with SPECT Imaging (Group B). This is the standard of care imaging. • For a positive SPECT perfusion scan, there are three scenarios that will make it • positive for trial endpoint surveillance: • 1) > 10% reversible defect size (Q16a) • 2) If SDS is > 7 (Q16c) • 3) Positive EKG changes for ischemia (Q9) and Transient Ischemic Dilation observed (Q18a) • 1-3 indicate a positive scan, therefore the response to Q19 should be Yes

  33. SP- SPECT MPI Reader Form (2 of 2) • If there were positive results found, the correct treatment should be “Diagnostic ICA” to (Q20) • If scans were negative the correct response should be “None” to (Q20) and the participant should be followed with OMT (Optimal Medical Therapy) per protocol and physician decision

  34. TS- SPECT Technical Assessment Form • Completed within one week of registration, documents if a SPECT was performed, and some imaging and contrast information associated with the SPECT (Group B). • SPECT MPI scans can collect images during rest and stress. Not all SPECT MPI scans require imaging during rest and vice versa. If rest images were only obtained at one sitting, the participant may be asked to have a repeat scan (SPECT or other type of scan) to try to image the heart during stress to capture ischemia. Stress images are captured while exercising, or if exercise is not tolerated, induced by medication.

  35. I2 Alternative Imaging Form • This form is optional and is used only if either the SPECT or the CCTA was non-diagnostic or uninterpretable. It will be triggered onto the case calendar automatically by the TS or TC form • Captures ‘crossover’ of randomization arm for analysis, information if scans are repeated, and primary endpoint data should another means of imaging be used for proper cardiac diagnosis

  36. I3 Randomized Alternate Imaging form This form is optional and is used only if either the randomized SPECT or the randomized CCTA were not performed. It will be triggered onto the case calendar automatically by the TS or TC form

  37. MA MACE Incident Form (1 of 2) • To be completed by Research Staff after a telephone call with the participant or proxy at two weeks and two months after enrollment for participants who have positive cardiac findings on diagnostic CCTA (> 50% left main stenosis) or SPECT MPI (> 10% reversible perfusion defect or EKG changes for ischemia with positive TID). • Form is triggered on the calendar for positive scans at baseline • Completed when participant has a heart attack, stroke, revascularization, or dies

  38. MA MACE Incident Form (2 of 2) • Events reported on this form are sent to the adjudication committee for review • With every MACE event, fax the participant contact sheet (excludes VA sites) to ACRIN DM dedicated fax line 215-940-8922

  39. MACE INCIDENT FORMSummary Follow up at the site will comprise telephone participant/proxy contact at 2 weeks and 2 months after enrollment only for participants who have positive cardiac findings on diagnostic CCTA or SPECT MPI. See protocol section 8.2.1 for additional details.

  40. F1 Follow Up Form • Completed by for all participants at various follow-up time points • The purpose is collect vital status, information pertaining to the diagnosis, treatment and procedures the participant has had during follow-up. It also captures optimal medical therapy (OMT) and medical provider information • Needs to be completed at each 6-month time point, whether contact is made with the participant or not. The form related to 6-month follow up, for example, should not be completed until contact has been made (four [4] attempts) or other confirmation of participant’s vital status (e.g., record review or known death) has been verified • The participant’s medical record should not be reviewed for vital status until contact at the final follow up time point has been attempted four (4) times. The final follow-up time point will be dependent on the enrollment timing of the participant

  41. F1 Follow Up Form (1 of 8)

  42. F1 Follow Up Form (2 of 8)

  43. F1 Follow Up Form (3 of 8)

  44. F1 Follow Up Form (6 of 8)

  45. F1 Follow Up Form (8 of 8) Q21: Were there any changes in the participant contact information since last contact or study follow-up? Answer = Yes, update Participant Contact Sheet and efax to 215-940-8922

  46. HS Participant Health Survey (1 of 3) • Completed at initial visit, and is a standardized research tool that measures quality of health • At the one year follow up there will be a randomized subset of participants who will be sent this questionnaire in the mail by the by the Outcomes Research Department of Brown University • If a VA institution participant is selected, it will be asked of the site and the VA participant to complete the form in the office and mail it directly to Brown University • If a non-VA institution participant is selected, it will be mailed to the participants home for completion and the participant will be required to mail it back to Brown University

  47. HS Participant Health Survey (2 of 3)

  48. HS Participant Health Survey (3 of 3)

  49. SA Seattle Angina Questionnaire • Completed at initial visit, and is a standardized subjective tool/questionnaire that measures the quality of health in persons who live with chest pain or angina • Just like the HS form, at the one year follow up there will be a randomized subset of participants who will be sent this questionnaire in the mail by the Outcomes Research Department of Brown University • If a VA institution participant is selected, it will be asked of the site and the VA participant to complete the form in the office and mail it directly to Brown University • If a non-VA institution participant is selected, it will be mailed to the participants home for completion and the participant will be required to mail it back to Brown University • Please note only page 1 of 3 is shown here

  50. LS Life Style Form(1 of 2) • Completed at baseline and 12 months

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