NCT01578876

Brief Summary

The purpose of this study is to determine the effectiveness of cardiac shock wave therapy (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at below P25 for phase_3 coronary-artery-disease

Timeline
Completed

Started Dec 2008

Typical duration for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

2.4 years

First QC Date

February 19, 2012

Last Update Submit

April 17, 2012

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaseangina pectorismyocardial ischemiacardiac shock wave therapy

Outcome Measures

Primary Outcomes (1)

  • Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease

    Outcome measure included clinical assessment and morphological assessment

    3 years

Study Arms (3)

CSWT for 3 month

EXPERIMENTAL

A group

Device: cardiac shock wave therapy(CSWT)

CSWT for 1 month

EXPERIMENTAL

B group

Device: cardiac shock wave therapy(CSWT)

Control group

NO INTERVENTION

C group

Interventions

cardiac shock wave therapy(CSWT)DEVICE

CSWT was performed with the MODULITH SLC SW therapy device (Storz Medical, Switzerland).Shock waves were triggered by the R-wave of the ECG when the instrument was activated. The shock wave energy was increased from an initial low level up 0.09 mJ/mm2 if the patient experienced no discomfort such as chest pain. Point-to-point combination treatment for the ischemic areas with 200 pulses delivered to each point was given.

Also known as: SW
CSWT for 1 monthCSWT for 3 month

Eligibility Criteria

Age35 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary angiography or multi-slice spiral ct coronary angiography suggestive of moderate to severe coronary artery stenosis.
  • Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment with or without stent or bypass graft).
  • Hospitalized more than 2 times within 1 year due to the aforementioned problems.
  • Canadian Cardiovascular Society angina grading higher than grade II, and New York Heart Association functional classification of I-III.
  • More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007.

You may not qualify if:

  • Acute myocardial infarction or coronary artery bypass graft within the 4 weeks prior to the study.
  • History of heart transplantation.
  • History of metal valve replacement surgery.
  • Intracardiac thrombus.
  • Left ventricular ejection fraction \< 30% and unstable hemodynamics.
  • Arrhythmia with a rate \< 40 bpm or \> 120 bpm.
  • Skin ulceration or infection in the treatment area.
  • Severe obstructive lung disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Center

Kunming, Yunnan, 0871, China

Location

Related Publications (1)

  • Nirala S, Wang Y, Peng YZ, Yang P, Guo T. Cardiac shock wave therapy shows better outcomes in the coronary artery disease patients in a long term. Eur Rev Med Pharmacol Sci. 2016;20(2):330-8.

    PMID: 26875905DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAngina PectorisMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guo Tao, MD

    Kunming Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiovascular Center

Study Record Dates

First Submitted

February 19, 2012

First Posted

April 17, 2012

Study Start

December 1, 2008

Primary Completion

May 1, 2011

Study Completion

January 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

CN(1)