NCT00776568

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

Enrollment Period

1.5 years

First QC Date

October 20, 2008

Last Update Submit

October 20, 2008

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (1)

  • Alleviation of anginal symptoms

    06 months

Secondary Outcomes (1)

  • The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model

    6 months

Study Arms (2)

2

ACTIVE COMPARATOR
Drug: Anti-hypertensive drugs

1

EXPERIMENTAL
Procedure: Extra-corporeal shockwave

Interventions

Extra-corporeal shockwavePROCEDURE

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.

1
Anti-hypertensive drugsDRUG

ACE inhibitors, Ca channel blockers, Beta blockers, Diuretics, Cholesterol lowering agents and/or other drugs used alone or in combination, as prescribed.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karachi Institute of Heart Diseases

Karachi, Pakistan

Location

Related Links

MeSH Terms

Conditions

Angina Pectoris

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Prof. Abdul Samad, MD

    Karachi Institute of Heart Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 21, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

PA(1)