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Table 2 Outcomes of the PRIMACY trial

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

Primary endpoints

1. Proportion of patients experiencing an improvement of 2 or more CCS angina classes.

Secondary endpoints

The secondary endpoints will compare the variation of the change from baseline to 6-month follow-up:

1. Wall motion score index by dobutamine stress echocardiogram

 

2. Exercise treadmill test

 

a. The variation (change from baseline) in time to 1 mm ST-segment depression (min);

 

b. Total exercise duration (min);

 

c. Maximal ST-segment depression (mm)

 

3. Proportion of patients experiencing an improvement of ≥ _ 1 CCS angina classes

 

4. MACE - the composite of cardiac death, major stroke, and myocardial infarction

 

5. The Seattle Angina Questionnaire scores, subdivided in categories

 

a. physical limitation;

 

b. anginal stability;

 

c. anginal frequency;

 

d. treatment satisfaction, and

 

e. disease perception

 

6. Reduction in reversible perfusion defect by SPECT

 

7. Regional oxygenation improvement measured by BOLD CMR (in selected centers only)

  1. BOLD blood oxygen level-dependent; CCS Canadian Cardiovascular Society; CMR cardiac magnetic resonance; MACE major adverse cardiac event; min, minutes; mm, millimeters; SPECT single-photon emission computed tomography.
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Trials

ISSN: 1745-6215