| Screening | Procedure | Discharge | 30 Days | 3 Months | 6 Months |
---|
Procedure
| | | | | | |
Informed consent | X | | | | | |
Medical history | X | | | | | |
Physical exam | X | | X | X | | X |
Listing of medication | X | | X | X | X | X |
Pregnancy test | X1
| | | | | |
Blood work | X1
| | | | | |
Cardiac enzymes | X2
| | X4
| | | |
ECG | X2
| | X | X | | X |
CCS assessment | X | | | X | X | X |
ETT | X | | | | | X |
Dobutamine echo | X | | | | | X |
Thallium/MIBI SPECT | X | | | | | X |
SAQ | X | | | X | X | X |
CMR | X | | | | | X |
RH catheterization | | X | | | | |
CS angiography | | X | | | | |
Randomization | | X | | | | |
Reducer implantation | | X3
| | | | |
CT angiogram | | | | | | X3
|
Adverse events | | X | X | X | X | X |
Serious adverse events | | X | X | X | X | X |
-
1Within seven days prior to procedure; 2within 24 hours prior to procedure; 3in Reducer group only, to be performed only after final assessments CCS angina class and SAQ; 4cardiac enzymes (CK, CK-MB, and troponin) within 8 to 12 hours post-procedure. CCS Canadian Cardiovascular Society; CMR cardiac magnetic resonance imaging; CS coronary sinus; CT computerized tomography; ECG electrocardiogram; ETT exercise tolerance test; MIBI sestamibi; RH right heart; SAQ Seattle Angina Questionnaire; SPECT single-photon emission computed tomography.