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Completed

NCT Number: NCT03053128

Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease

Coronary heart disease (CHD) is a public health care challenge. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT. There are only three cities in China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

About this study

Coronary heart disease (CHD) is a public health care challenge, which lead to 3.5 millions of people died in China every year. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients with severe cardiac ischemia lost the chance to get those treatment. Their quality of life is influenced by recurrent angina. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. German and Japan are the countries earliest used CSWT. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT by objective examination. New small vessels generation on ischemia area was found on mice and pig model. There are only three cities in China run the program of CSWT, that are Kunming, Beijing and Shanghai. Beijing hospital has the only CSWT machine in Beijing. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiple or diffused coronary artery stenosis by coronary angiography and not candidate for PCI or CABG;
  • Myocardial ischemia and/or cardiac dysfunction by objective exams;
  • Angina and/or heart failure could not be control after optimal medication treatment for coronary artery disease;
  • LVEF is above 30%;
  • Signed informed consent

Exclusion criteria

  • Acute myocardial infarction;
  • Within one month after PCI or CABG;
  • Heart transplant patient;
  • Mechanic valve implantation patient;
  • Uncontrolled heart failure with LVEF less than 30%;
  • Severe arrhythmia;
  • Pacemaker implantation patient;
  • Infective endocarditis;
  • Severe chronic obstructive pulmonary disease patient;
  • Pregnant or nursing patient;
  • Silicone breast forms patient;
  • Chest tumor patient;
  • Participant in other clinical trials at the same time.

Treatment and study plan

Cardiac shock wave therapy

Device

Patients in CSWT group will receive CSWT for a 3-month therapy, located in their ischemia area with a energy of 0.09mJ/mm2. Patients will get therapy on every first week of the month and rest for following three weeks.

Other names: CSWT group

Sham cardiac shock wave (Control group)

Other

Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.

Other names: Sham CSWT group

Primary outcomes

  1. Myocardial perfusion score

    Time frame: 1st week of fourth month from beginning of CSWT

    Myocardial perfusion score will be calculated by myocardial perfusion imaging though single-photon computer tomography.

  2. Ischemia area percentage

    Time frame: 1st week of fourth month from beginning of CSWT

    Ischemia area will be calculated by myocardial perfusion imaging though single-photon computer tomography.

Secondary outcomes

  1. Cardiac wall motion amplitude

    Time frame: 1st week of fourth month from beginning of CSWT

    Cardiac wall motion amplitude rate will be calculated by single-photon computer tomography.

  2. Left ventricular thickness rate

    Time frame: 1st week of fourth month from beginning of CSWT

    Left ventricular thickness rate will be calculated by single-photon computer tomography.

  3. Cardiac enzyme

    Time frame: First week after CSWT

    Troponin T and troponin I will be tested at last time shock wave therapy of the first week.

  4. Angina score-SAQ

    Time frame: 1st week of fourth month from beginning of CSWT

    SAQ angina score will be finished after three month of CSWT.

  5. Quality of life (SF-36)

    Time frame: 1st week of fourth month from beginning of CSWT

    SF-36 questionnaire will be used for QOL.

  6. Six-minute of walk test

    Time frame: 1st week of fourth month from beginning of CSWT

    6MWT will be used for exertional capacity.

Sponsors and collaborators

Lead sponsor

Beijing Hospital

Other Gov

Registry information

Official study title

Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease: A Prospective Randomized Double-blind Control Trial

Acronym: CSWT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 14, 2017
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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