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CIRCULAT Study in Chronic Ischemic Heart Disease Patrick J. Lynch, 2006

CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

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CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

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Page 1: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

CIRCULAT Study in Chronic Ischemic

Heart Disease

Patrick J. Lynch, 2006

Page 2: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

Background: Endothelial Damage

NORMAL ARTERY ATHEROSCLEROTIC PLAQUENARROWED ARTERY

ENDOTHELIUM

SMOOTH MUSCLE

SMOOTH MUSCLECELLS

MACROPHAGESTRANSFORMED

INTO FOAM CELLSLIPIDS, CALCIUM

CELLULAR DEBRIS

FIBROUS CAP.

ENDOTHELIUMDAMAGE

ENDOTHELIALDYSFUNCTION

MECHANICALSTREESS

HYPERTENSION

VASOCONSTRICTION

PERIPHERALVASCULAR RESISTANCE

Page 3: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

Relevant Mortality Rates in Venezuela

Page 4: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

Chronic Ischemic Heart

Disease GSPECT Assessment

(Independant Lab)

Treadmill

Imaging

Page 5: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

Chronic Ischemic Heart

Disease GSPECT Assessment

(Independant Lab)

Assessment

Page 6: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Cardio-Diagnostic Imaging(Source: www.yale.edu/imaging/)

Annualized Cardiac Events Risk

Treatment Implications(majority of patients)

<1% risk of cardiac deathand MI

Risk factor modification (RFM) in addition to current regimen

Low risk of cardiac death; Intermediate risk of MI

Aggressive RFM/medicaltreatment

Intermediate-to-high riskof both cardiac death/MI

Catheterization (possiblerevascularization)/RFM

Normal Mildly Normal Moderately / Severely Abnormal

anterior

inferior

septal lat

anterior

inferior

base apex

apex

latseptal

base

Page 7: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

Chronic Ischemic Heart Disease treatment with complex herbal formulation Study

Roberto Guzmán, José Olalde, Francis Amendola, Oswaldo del Castillo

Results: Good response (17 out of 20 initial patients) to therapy was observed in 85% of the patients (p ≤ 6.104e-05; %=99.9999) as determined by Wilcoxon. No patient suffered adverse

events or died during the studied period.

*Results ranging between six months and one year; in first 20 out of 30 total Patients under study

One PatientDiffuse Captation

Lateral WallQualitative

20 Patients *

3 PatientsSame Perfusion Defect

Quantitative

One PatientDiffuse Captation

Inferior WallQualitative

15 PatientsPerfusion Defect

Quantitative

3 PatientsSame Captation

Lateral / Inferior WallQualitative

17 PatientsImprovement

15 Quant + 2 Qual+ + =

3 PatientsNo Improvement= =

Page 8: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

Study Aditional Hightlights (1)

Page 9: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

Study Aditional Hightlights (2)

Page 10: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 40

29 APR 2009

16 SEP2009

PD%: Post–Effort Perfusion Damage Percentage

GSPECT Image

PD%: 35

Control

6 months

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Total452

post-treatment

386Time (sec)

pre-treatment

66Increase (sec)

6 month treatment

Patient 1

Page 11: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 45

13 MAY 2009

28 OCT2009

GSPECT Image

PD%: 30

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

7 JUL2010

PD%: 15

One year

Chronic Ischemic Heart Disease One year treatment study

Funtional Capacity Time (sec)

Patient unable to carry out the test due physical limitations

Patient 2

Page 12: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 20

20 MAY 2009

28 OCT2009

PD%: 10

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

16 JUN2010

PD%: 10

One year

Chronic Ischemic Heart Disease One year treatment study

Funtional Capacity Time (sec)

Total442

post-treatment

366Time (sec)

pre-treatment

76Increase (sec)

6 month treatment

Patient 3

Page 13: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 70

03 JUN 2009

11 NOV2009

PD%: 60

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Total200

post-treatment

155Time (sec)

pre-treatment

45Increase (sec)

6 month treatment

Patient 4

Page 14: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 30

06 MAY 2009

07 OCT2009

PD%: 25

Control

6 months

09 JUL2010

PD%: 0

One year

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease One year treatment study

Funtional Capacity Time (sec)

Total615

post-treatment

486Time (sec)

pre-treatment

81Increase (sec)

6 month treatment

48Increase (sec)

1 year treatment

Patient 5

Page 15: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 30

06 MAY 2009

07 OCT2009

PD%: 20

Control

6 months

09 JUN2010

PD%: 20

One year

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease One year treatment study

Funtional Capacity Time (sec)

Total662

post-treatment

553Time (sec)

pre-treatment

88Increase (sec)

6 month treatment

14Increase (sec)

1 year treatment

Patient 6

Page 16: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 15

29 APR 2009

16 SEP2009

PD%: Post–Effort Perfusion Damage Percentage

GSPECT Image

PD%: 15

Control

6 months

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Total609

post-treatment

555Time (sec)

pre-treatment

54Increase (sec)

6 month treatment

Patient 7

Page 17: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 10

14 JUL 2009

11 NOV2009

GSPECT Image

PD%: 5

Control

6 months

28 JUL2010

PD%: 5

One year

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease One year treatment study

Funtional Capacity Time (sec)

Total491

post-treatment

433Time (sec)

pre-treatment

68Increase (sec)

6 month treatment

-10Decrease (sec) 1 year treatment

Patient 8

Page 18: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 20

14 JUL 2009

11 NOV2009

PD%: 20

Control

6 months

04 AGO2010

PD%: 20

One year

PD%: Post–Effort Perfusion Damage Percentage

GSPECT ImageChronic Ischemic Heart Disease One year treatment study

Funtional Capacity Time (sec)

Total676

post-treatment

516Time (sec)

pre-treatment

132Increase (sec)

6 month treatment

28Increase (sec)

1 year treatment

Patient 9

Page 19: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 60

13 MAY 2009

07 OCT2009

GSPECT Image

PD%: 35

Control

6 months

02 JUN2010

PD%: 20

One year

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease One year treatment study

Funtional Capacity Time (sec)

Total428

post-treatment

339Time (sec)

pre-treatment

89Increase (sec)

6 month treatment

Patient 10

Page 20: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 25

12 AGO 2009

08 DEC2009

PD%: Post–Effort Perfusion Damage Percentage

GSPECT Image

PD%: 15

Control

6 months

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Total373

post-treatment

323Time (sec)

pre-treatment

50Increase (sec)

6 month treatment

Patient 11

Page 21: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 15

14 JUL 2009

02 DEC2009

GSPECT Image

PD%: 0

Control

6 months

04 AGO2010

PD%: 0

One year

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease One year treatment study

Funtional Capacity Time (sec)

Total570

post-treatment

432Time (sec)

pre-treatment

83Increase (sec)

6 month treatment

55Increase (sec)

1 year treatment

Patient 12

Page 22: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

PD%: 25

23 JUL 2009

02 DEC2009

PD%: Post–Effort Perfusion Damage Percentage

GSPECT Image

PD%: 20

Control

6 months

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Patient unable to carry out the test due physical limitations

Patient 13

Page 23: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 70

11 MAR 2010

15 SEP2010

PD%: 55

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Total235

post-treatment

209Time (sec)

pre-treatment

26Increase (sec)

6 month treatment

Patient 14

Page 24: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 95

04 MAR 2010

15 SEP2010

PD%: 90

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Patient unable to carry out the test due physical limitations

Patient 15

Page 25: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 35

10 MAR 2010

1 SEP2010

PD%: 35

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Patient unable to carry out the test due physical limitations

Patient 16*

* Slight Qualitative Perfusion Improvement determined by diffuse radioisotope captation in lateral wall

Page 26: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 50

17 MAR 2010

15 SEP2010

PD%: 35

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Total254

post-treatment

333Time (sec)

pre-treatment

-79Decrease (sec)

6 month treatment

Patient 17

Page 27: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 50

17 MAR 2010

06 SEP2010

PD%: 35

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Total549

post-treatment

479Time (sec)

pre-treatment

70Increase (sec)

6 month treatment

Patient 18

Page 28: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 45

03 MAR 2010

01 SEP2010

PD%: 45

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Total620

post-treatment

610Time (sec)

pre-treatment

10Increase (sec)

6 month treatment

Patient 19*

* Important Qualitative Perfusion Improvement determined by diffuse radioisotope captation in inferior wall

Page 29: CIRCULAT Study in Chronic Ischemic Heart Disease (20 Pat)

GSPECT Image

PD%: 15

10 MAR2010

15 SEP2010

PD%: 15

Control

6 months

PD%: Post–Effort Perfusion Damage Percentage

Chronic Ischemic Heart Disease Six month treatment study

Funtional Capacity Time (sec)

Patient unable to carry out the test due physical limitations

Patient 20