Treatment of Refractory Angina Pectoris by Shock Wave Therapy

Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Refractory Angina Pectoris

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.

Study Overview

• Status: Unknown
• Conditions: Angina Pectoris
• Intervention / Treatment: Drug: Anti-hypertensive drugs; Procedure: Extra-corporeal shockwave

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • Karachi Institute of Heart Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Alleviation of anginal symptoms	06 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model	6 months

Collaborators and Investigators

• Sponsor: Universal Research Group
• Collaborators: UNIQUIP INTERNATIONAL, Pakistan
• Investigators: Principal Investigator: Prof. Abdul Samad, MD, Karachi Institute of Heart Diseases

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: October 20, 2008
• First Submitted That Met QC Criteria: October 20, 2008
• First Posted (Estimate): October 21, 2008

Study Record Updates

• Last Update Posted (Estimate): October 21, 2008
• Last Update Submitted That Met QC Criteria: October 20, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Antihypertensive Agents
• Other Study ID Numbers: URG/UQ/002/01; ISRCTN68966125