Back to resultsTreatment of Refractory Angina Pectoris by Shock Wave Therapy
Primary Purpose
Angina Pectoris
Status
Unknown status
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Extra-corporeal shockwave
Anti-hypertensive drugs
Sponsored by
About this trial
This is an interventional treatment trial for Angina Pectoris
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18 years or older.
- Diagnosis of chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise Single-Photon Emission Computed Tomography (Exercise SPECT).
- Patient has documented myocardial segments with reversible ischemia and or hibernation.
- Patient is classified as AP CCS of III or IV.
- Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- Patients demonstrates exercise tolerance time (ETT) duration <10 minutes on a modified Bruce protocol on 2 consecutive tests (tests no less than 24 hours and no more than 2 weeks apart), with the second test within 25% of the first (Patients should not be informed of exercise restrictions required for entry into the study).
- Patient has refused to undergo another angioplasty or CABG.
- Patient has signed an informed consent form.
- Patient's condition should be stable and should have a life expectancy of >12 months.
- Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.
- Newly diagnosed type II diabetes.
Exclusion Criteria:
- Chronic lung disease including emphysema and pulmonary fibrosis.
- Active endocarditis, myocarditis or pericarditis.
- Patient is simultaneously participating in another device or drug study, or has participated in any
- Clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
- Patients who are unwilling or unable to cooperate with study procedure.
- Patients who are unwilling to quit smoking during the study procedure (including screening phase)
- Patients who had myocardial infarction (MI) less than 3 months prior to treatment.
- Patients who are diagnosed with a 3rd and 4th degree heart valve disease.
- Patient with intraventricular thrombus.
- Pregnancy.
- Patient with a malignancy in the area of treatment.
Sites / Locations
- Karachi Institute of Heart Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2
1
Arm Description
Outcomes
Primary Outcome Measures
Alleviation of anginal symptoms
Secondary Outcome Measures
The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model
Full Information
NCT ID
NCT00776568
First Posted
October 20, 2008
Last Updated
October 20, 2008
Sponsor
Universal Research Group
Collaborators
UNIQUIP INTERNATIONAL, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT00776568
Brief Title
Treatment of Refractory Angina Pectoris by Shock Wave Therapy
Official Title
Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Refractory Angina Pectoris
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Universal Research Group
Collaborators
UNIQUIP INTERNATIONAL, Pakistan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine that extracorporeal shock wave therapy (ESWT) is safe and effective for the treatment of refractory angina pectoris.
Detailed Description
Patients with advanced CAD frequently have limited symptoms with recurrent angina, angina at low work thresholds, breathlessness, and other debilitating conditions. These patients have often been through several "re-do" coronary bypass procedures and multiple percutaneous coronary interventions.
Surgical and interventional options for these patients typically have been exhausted or will result in only partial revascularization. Therefore, therapy remains limited to the use of multiple anti-anginal medications, reduced activity, exertion, and stress level, and significant alteration and limitation of lifestyle.
The goal of this emerging approach is to therapeutically induce the growth and development of new vasculature in zones of severe ischemia in the myocardium, with the hope that new capillaries and arterioles generated will connect to remnant existing vasculature. These neovessels are viewed to act as collaterals, perfusing ischemic territories unapproachable by macro procedures such as PCI and/or CABG.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Extra-corporeal shockwave
Intervention Description
Low intensity shock waves are applied as 300 shocks per visit for 09 visits. The treatment visit is carried at week 1, 5 and 9.
Intervention Type
Drug
Intervention Name(s)
Anti-hypertensive drugs
Intervention Description
ACE inhibitors, Ca channel blockers, Beta blockers, Diuretics, Cholesterol lowering agents and/or other drugs used alone or in combination, as prescribed.
Primary Outcome Measure Information:
Title
Alleviation of anginal symptoms
Time Frame
06 months
Secondary Outcome Measure Information:
Title
The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 years or older.
Diagnosis of chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise Single-Photon Emission Computed Tomography (Exercise SPECT).
Patient has documented myocardial segments with reversible ischemia and or hibernation.
Patient is classified as AP CCS of III or IV.
Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
Patients demonstrates exercise tolerance time (ETT) duration <10 minutes on a modified Bruce protocol on 2 consecutive tests (tests no less than 24 hours and no more than 2 weeks apart), with the second test within 25% of the first (Patients should not be informed of exercise restrictions required for entry into the study).
Patient has refused to undergo another angioplasty or CABG.
Patient has signed an informed consent form.
Patient's condition should be stable and should have a life expectancy of >12 months.
Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.
Newly diagnosed type II diabetes.
Exclusion Criteria:
Chronic lung disease including emphysema and pulmonary fibrosis.
Active endocarditis, myocarditis or pericarditis.
Patient is simultaneously participating in another device or drug study, or has participated in any
Clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
Patients who are unwilling or unable to cooperate with study procedure.
Patients who are unwilling to quit smoking during the study procedure (including screening phase)
Patients who had myocardial infarction (MI) less than 3 months prior to treatment.
Patients who are diagnosed with a 3rd and 4th degree heart valve disease.
Patient with intraventricular thrombus.
Pregnancy.
Patient with a malignancy in the area of treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Abdul Samad, MD
Organizational Affiliation
Karachi Institute of Heart Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karachi Institute of Heart Diseases
City
Karachi
Country
Pakistan
12. IPD Sharing Statement
Links:
URL
http://www.controlled-trials.com/ISRCTN68966125
Description
Related Info
Learn more about this trial
Treatment of Refractory Angina Pectoris by Shock Wave Therapy
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