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Table 2 The primary, secondary endpoints and other characteristics of the imaging tests

From: The effect of cardiac shock wave therapy on myocardial function and perfusion in the randomized, triple-blind, sham-procedure controlled study

 

OMT + CSWT group

OMT + sham procedure group

Baseline

3- month

6- month

Baseline

3- month

6- month

Primary endpoints

 WMSI at stress during DSE

1.6 ± 0.4

1.4 ± 0.4*

1.4 ± 0.3*

1.6 ± 0.4

1.5 ± 0.3

1.4 ± 0.3*

 SDS during SPECT#

5.5 [3.3; 7.0]

3.0 [0; 5.0]*, &

4.0 [3.0; 9.0])

5.0 [3.0; 8.0]

Secondary endpoints

 WMS at stress during DSE

26.8 ± 7.0

24.2 ± 7.3*

23.1 ± 5.8*

26.3 ± 6.5

25.0 ± 5.7

23.5 ± 5.1*

 LVEF at stress during DSE, %

49.8 ± 11.2

54.1 ± 12.3*

56.8 ± 9.4*

51.6 ± 11.0

53.4 ± 11.6

53.7 ± 9.7

 Number of patients with at least moderate ischemia in DSE, n (%)

17 (57)

6 (21)*

5 (18)*

14 (48)

10 (36)

9 (35)

 Number of patients with at least moderate ischemia in SPECT, n (%)

22 (73)

12 (46)*

21 (72.4)

17 (68)

 ECG changes during stress DSE, n (%)

22 (73)

13 (46)*, &

13 (46)*

19 (66)

21 (75)

16 (62)

 Angina during stress DSE, n (%)

23 (77)

12 (43)*

10 (36)*

18 (62)

13 (46)

11 (42)*

 Global PSS at stress during DSE, %

−15.0 ± 3.2

−13.7 ± 3.0

−14.0 ± 2.3

−15.1 ± 4.5

− 13.7 ± 3.6

−13.6 ± 2.4

 Summed stress score (SSS) during SPECT#

8.5 [5.3; 12.8]

5.0 [2.0; 12.0]*

10.0 [4.0; 15.0]

8.0 [3.0; 14.0]

 TPD at stress during SPECT, %#

13.0 [6.3; 18.8]

7.0 [3.0; 17.5]*

15.0 [6.0; 22.0]

12.0 [4.0; 20.0]

 TPD at rest during SPECT, %#

2.0 [0; 7.8]

0 [0; 7.0])

2.0 [0; 10.0])

3.0 [0; 9.0]

 TPD difference during SPECT, %

7.0 [4.3; 11.0]

4.0 [0; 7.0]*,&

7.0 [5.0; 13.0]

7.0 [4.0; 12.0]

Other tests characteristics

 WMS at rest during DSE

23.4 ± 7.8

23.6 ± 7.8

22.6 ± 6.4

23.8 ± 7.0

24.3 ± 6.9

22.8 ± 5.7

 WMSI at rest during DSE

1.4 ± 0.5

1.4 ± 0.5

1.3 ± 0.4

1.4 ± 0.4

1.4 ± 0.4

1.3 ± 0.3

 LVEF at rest during DSE, %

46.5 ± 10.6

47.3 ± 11.0

49.8 ± 8.6*

48.5 ± 9.0

48.2 ± 8.6

48.5 ± 8.1

 Number of positive DSE tests, n (%)

21 (70)

10 (36)*

8 (29)*

20 (69)

13 (46)

11 (4)

 Number of positive SPECT tests, n (%)

28 (93)

18 (69)*

28 (96)

21 (84)

 Global PSS at rest, %

−14.8 ± 3.4

−13.2 ± 3.8

−13.9 ± 2.7

−14.1 ± 2.2

−13.5 ± 2.6

−13.0 ± 1.9

 SRS during SPECT#

1.0 [0; 5.8]

0 [0; 5.0]

2.0 [0; 7.0]

 

2.0 [0; 6.0]

  1. WMSI wall motion score index, SDS summed difference score, DSE dobutamine stress echocardiography, SPECT single photon emission computed tomography, SRS summed rest score, ECG electrocardiogram, CH chamber view, CSWT Cardiac shock wave therapy, LVEF left ventricular ejection fraction, OMT optimal medical therapy, PSS peak systolic strain
  2. Moderate ischemia was defined as ≥3 segments with stress induced severe hypokinesis or akinesis in DSE and as SDS 4–7 in SPECT
  3. *- P < 0.05, comparison of follow up to baseline in the group, &- P < 0.05, comparison between study groups, # -values are presented as median [Interquartile range]