IS IT A PROTOCOL VIOLATION IF A PATIENT HAS AN EXERCISE TOLERANCE TEST BEFORE THE 4-MONTH FOLLOW UP?
ANSWER – The Rita-3 protocol states that “additional exercise treadmill tests should be carried out only for compelling clinical indications”. If the supervising clinician decides to exercise a patient before the 4 month follow up, the protocol must be strictly adhered to when deciding if the patient requires arteriography and therefore cross over into the intervention arm of the trial. If the supervising clinician follows the protocol then it is not a protocol violation. QUESTION – IF A PATIENT WAS MISSED FOR THE FIRST 48 HRS OF HIS INDEX ADMISSION BUT SUBSEQUENTLY DEVELOPED FURTHER CHEST PAIN AT REST, CAN THIS SUBSEQUENT EPISODE OF PAIN BE USED TO RANDOMISE THE PATIENT? ANSWER – Yes, any episode of chest pain at rest can be used as long as the patient fits the inclusion/exclusion criteria. For example, if a patient is admitted to hospital with chest pain at rest but for whatever reason is not randomised within 48 hours of the onset of pain, the research assistant may use any subseque
