Treatment of Refractory Angina Pectoris by Shock Wave Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Universal Research Group.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Universal Research Group
Collaborator:
UNIQUIP INTERNATIONAL, Pakistan
Information provided by:
Universal Research Group
ClinicalTrials.gov Identifier:
NCT00776568
First received: October 20, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Angina Pectoris |
Procedure: Extra-corporeal shockwave Drug: Anti-hypertensive drugs |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Refractory Angina Pectoris |
Resource links provided by NLM:
Further study details as provided by Universal Research Group:
Primary Outcome Measures:
- Alleviation of anginal symptoms [ Time Frame: 06 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 60 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2 |
Drug: Anti-hypertensive drugs
ACE inhibitors, Ca channel blockers, Beta blockers, Diuretics, Cholesterol lowering agents and/or other drugs used alone or in combination, as prescribed.
|
| Experimental: 1 |
Procedure: Extra-corporeal shockwave
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776568
Locations
| Pakistan | |
| Karachi Institute of Heart Diseases | |
| Karachi, Pakistan | |
Sponsors and Collaborators
Universal Research Group
UNIQUIP INTERNATIONAL, Pakistan
Investigators
| Principal Investigator: | Prof. Abdul Samad, MD | Karachi Institute of Heart Diseases |
More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Director, Karachi Institute of Heart Diseases |
| ClinicalTrials.gov Identifier: | NCT00776568 History of Changes |
| Other Study ID Numbers: | URG/UQ/002/01, ISRCTN68966125 |
| Study First Received: | October 20, 2008 |
| Last Updated: | October 20, 2008 |
| Health Authority: | Pakistan: Ministry of Health |
Additional relevant MeSH terms:
|
Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain |
Pain Signs and Symptoms Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013