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Table 3 Study procedures

From: A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial

 

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

  1. 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.