Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00776568
Protocol/serial number
URG/UQ/002/01
Study information
Scientific title
Extracorporeal shock wave therapy (ESWT) for the treatment of refractory angina pectoris
Acronym
Study hypothesis
Patients with advanced coronary artery disease (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 revascularisation. 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 angioplasty and bypass surgery.
Ethics approval
The IEC/IRB, City Medical Committee, Karachi (Pakistan). Date of approval: 25/02/2008 (ref: ERB/KIHD/001)
Study design
Randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Coronary artery disease
Intervention
In this study, all participants will receive the same interventions (there is no control group). Each participant will serve as their own control; comparison will be made between their first SPECT and follow-up SPECT.
Efficacy:
1. The patient will be positioned on the treatment table and connected to the ECG monitor.
2. The treatment area to be treated will be localized by cardiologic ultrasound.
3. The treatment area should be divided to a 1 x 1 cm zones. At least three (minimum zones) different myocardial zones are to be treated with shock waves.
4. Ultrasound gel must be applied on the shock wave applicator (SWA) membrane and on the patient's chest skin that is in contact with the SWA. The SWA will be mounted to the Cardiospec according to the ultrasound localisation of the treatment area. The SWA membrane should be inflated to achieve full contact with the patient's skin.
5. Shock waves are applied concomitantly with ultrasound imaging on the myocardial locations.
6. The energy level will be a flux density of 0.09 mj/mm2, and will remain at this level throughout each session. Each myocardial zone will be treated with approximately 100 shocks.
7. At least 2,700 shocks will be applied over a course of 9 treatment sessions.
Safety - the following will be monitored during the interventions:
1. Incidence of patient complications
2. Adverse reactions
3. Rise in cardiac enzymes
4. Blood count
5. Troponin levels
6. Electrocardiogram (ECG) changes
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Therapeutic effect. The following will be assessed at baseline and 6 months post baseline or at the last visit for patients who terminate prematurely:
1.2. Alleviation of anginal symptoms
1.2. Improved myocardial perfusion
1.3. To determine whether the shock wave therapy serves as an adjuvant therapy for the treatment of refractory angina pectoris
2. Change in maximal stress exercise capacity testing. The change in total exercise time assessed using the modified Bruce exercise test, from baseline to 6 months post-baseline, or to the last visit for patients who terminate prematurely.
Secondary outcome measures
1. Change in cardiac enzymes before and after the first treatment
2. The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model)
3. AP CCS Stage: The AP CCS Stage at 6 months post-baseline, or at the last visit for patients who terminate prematurely
4. The change in the number of angina attacks from baseline to 6 months post-baseline. The number of attacks per week will be documented
5. Hospital Admission Rate: The change in the number of hospital admission from baseline to 6 months post-baseline. The number of admissions per month will be documented.
Overall trial start date
26/02/2008
Overall trial end date
28/11/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female, 18 years or older.
2. Diagnosis of chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise Single-Photon Emission Computed Tomography (Exercise SPECT).
3. Patient has documented myocardial segments with reversible ischemia and or hibernation.
4. Patient is classified as AP CCS of III or IV.
5. Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
6. 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).
7. Patient has refused to undergo another angioplasty or CABG.
8. Patient has signed an informed consent form.
9. Patient's condition should be stable and should have a life expectancy of >12 months.
10. 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.
11. Newly diagnosed type II diabetes.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Chronic lung disease including emphysema and pulmonary fibrosis.
2. Active endocarditis, myocarditis or pericarditis.
3. Patient is simultaneously participating in another device or drug study, or has participated in any
4. 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.
5. Patients who are unwilling or unable to cooperate with study procedure.
6. Patients who are unwilling to quit smoking during the study procedure (including screening phase)
7. Patients who had myocardial infarction (MI) less than 3 months prior to treatment.
8. Patients who are diagnosed with a 3rd and 4th degree heart valve disease.
9. Patient with intraventricular thrombus.
10. Pregnancy.
11. Patient with a malignancy in the area of treatment.
Recruitment start date
26/02/2008
Recruitment end date
28/11/2008
Locations
Countries of recruitment
Pakistan
Trial participating centre
B-84
Karachi
-
Pakistan
Funders
Funder type
Industry
Funder name
Government and private collaboration:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
UNIQUIP International (main funder) (Pakistan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
City District Government Karachi (funding the investigator and providing facility) (Pakistan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list