Welcome to the GEMINI ACS 1 Test Your Knowledge Review! This page serves as a repository for the Test Your Knowledge questions and correct answers. Check back weekly for updates!
Test Your Knowledge Review (Updated 13 June 2016)
|June 13, 2016||Last weeks' quiz, was about Subject 123456, who is enrolled in the GEMINI study. He went to the emergency department with chest pain. The emergency physician, Dr. Cardio, performs an ECG and draws a CKMB, CK and a hs Troponin T. The ECG is unremarkable and the results of the cardiac biomarkers are all within normal range. Dr. Cardio diagnoses the chest pain as indigestion. This is considered a reportable Cardiac Outcome Event. What source documents should be submitted to DCRI CEC via Intralinks?||Event checklist coversheet, Event ECGs (baseline/pre-event, event and post-event tracings), all cardiac biomarkers with ULN, discharge summary, other cardiac diagnostic procedure results and reports, if applicable (angiogram, PCI/CABG).
For Cardiac Events and Stent Thrombosis Events associated with a cardiac event, an ECG is required (if available):
Please refer to the GEMINI Clinical Event Committee Site Manual. The Site Manual provides all event checklist coversheets and a listing of all required documents for all outcome events.
|June 6, 2016||Subject 123456 is enrolled in the GEMINI study. He has just come home from his Day 270 study visit with his cardiologist, Dr. Heart. He is happy because Dr. Heart said he is doing well and there are no issues. He decides to celebrate at home with champagne and a thick juicy steak. After dinner, he feels some chest pain. His wife brings him to the emergency department. The emergency physician, Dr. Cardio, performs an ECG and draws a CKMB, CK, and his Troponin T. The ECG is unremarkable and the results of the cardiac biomarkers are all within normal range. Dr. Cardio diagnoses the chest pain as indigestion. How should the chest pain be diagnosed?||Reported as a Cardiac Outcome Event on the eCRF.
Report any chest pain event or suspected cardiac ischemic event (regardless of the final diagnosis) that prompts emergency department evaluation and/or hospitalization, as well as any emergency department evaluation and/or hospitalization during which cardiac biomarkers were found to be elevated (regardless of the perceived reason for elevated cardiac biomarkers) on the cardiac event page.
|May 16, 2016||1. Subject was admitted as a STEMI subject on 15 October 2015 then randomized and administered the 1st dose of study drug on 20 October 2015. They experienced an outcome event on Study Day 85 which required temporarily discontinuation of study drug from 15 January 2016 to 24 January 2016. What is the first date the subject could have their End of Study visit?
2. A subject was randomized on 25 June 2015. They permanently discontinued study drug on 15 July 2015. Their final dose and Follow-Up visits, respectively, occurred on 02 July 2015 and 01 August 2015. Which of the following dates is viable for their Final Study Visit?
|1. September 11, 2016
The subject's targeted 360 Day visit would be after the Study Treatment End Date (STED) of 22 August 2016, therefore the subject would come in for their End of Treatment Visit as the STED range (+14 days) between 22 August 2016 and 04 September 2016. Assuming they come in on 22 August 2016 and this is the last dose of study drug then the first possible End of Study Visit would be 30 days after the last dose. Per the protocol specified windows the End of Study visit should occur 30 days (-10/+15 days) after the last dose of study drug. By these calculations, the first date the subject could have their End of Study visit is 11 September 2016.
2. June 24, 2016
|May 09, 2016||1. The subject was randomized on June 1, 2015; they permanently discontinued study drug early on March 5, 2016, they had their follow up visit 30 days (-10/+15 days) after the last dose on April 7, 2016. What is a possible date for the subject's Final Study Visit?
2. The subject was randomized on January 2, 2016, they continue on study drug reaching Study Treatment End Date (STED) on August 22, 2016. They have their End Of Treatment (EOT) visit on August 24, 2016. What is a possible date for the subject's End Of Study (EOS) visit?
|1. May 29, 2016
The subject has already had their follow up visit 30 days after the last dose (-10/+15), their Final Study Visit would be 360 Days from randomization (+14day window); this makes the window for the Final Study Visit between May 27, 2016 to June 10, 2016.
2. September 29, 2016
|May 02, 2016||1. A subject is considered to have completed the double blind treatment period if the subject reaches their planned Day 360 OR reaches the Study Treatment End Date (STED) on study drug. True or False?
2. For a subject who reaches STED (22 August 2016) before their planned Day 360; study drug should be discontinued on 22 August 2016, even though the End of Treatment (EOT) visit is scheduled on 25 August 2016. True or False?
3.A subject is considered to have completed the study if they have permanently discontinued study drug AND been followed until the End Of Study (EOS) Visit or has died. True or False?
A subject will be considered as having completed the double-blind treatment period if the subject continues taking study drug until either the end of their planned double-blind treatment phase (Day 360 or STED).
|April 25, 2016||1. A subject was randomized on 16 June 2015. Will they meet Day 360 or STED (Study Treatment End Date) first?
2. The subject's Day 270 visit is scheduled to occur on 29 August 2016; this visit is not necessary. True or False?
|1. Day 360
They will meet Day 360 first as the date of the visit is prior to the STED of 22 August 2016.
|October 14, 2015||A subject develops ACS symptoms at 03:33 am on 08-October-2015 and is admitted to a local hospital at 5:42 am on 08-October-2015 then subsequently transferred and admitted to a regional hospital at 09:50 am on 09-October-2015. What is the latest date and time the subject can be randomized?||11:59 pm on 17-October-2015
Subjects must be randomized within the screening window of 10 days after hospitalization for the index ACS event. The day of hospital admission is Day 1 of screening and randomization must occur within 10 calendar days (counting the day of hospitalization and the day of randomization).
If a subject is transferred from another hospital for their index ACS event, the date of the initial hospital admission is to be counted as Day 1 of the screening window. If a Subject is hospitalized for a condition other than ACS and develop an ACS event (excluding MI associated with a revascularization procedure) while hospitalized, the onset of the ACS event will count as Day 1 of the screening window, rather than the initial hospitalization.