Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study

NCT ID: NCT03398096

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2018-09-30

Brief Summary

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Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to evaluate the safety and efficiency of CSWT in the treatment of refractory angina.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cardiac shock wave therapy (CSWT) group

The CWST group were performed with a CSWT equipment (Storz Medical, Switzerland) followed the recommended protocol developed by Tohoku University of Japan with respect to the shockwave output and the number of shots implemented to each spot and the protocol developed by the University of Essen, Germany.

Group Type EXPERIMENTAL

Cardiac shock wave therapy

Intervention Type DEVICE

Ultrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease.

Control group

No CWST treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cardiac shock wave therapy

Ultrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients were 18 to 80 years old;
* Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) 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;
* CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III;
* More than 1 month after acute myocardial infarction (AMI) and 1 month after percutaneous coronary intervention (PCI) surgery.

Exclusion Criteria

* AMI态PCI or coronary artery bypass graft (CABG) within the 4 weeks prior to the study;
* History of heart transplantation;
* History of metal valve replacement surgery;
* Intra-cardiac thrombus;
* Left Ventricular Ejection Fraction (LVEF) \< 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Weijing Liu

Role: CONTACT

18917684041

References

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Weijing L, Ximin F, Jianying S, Mengyun Z, Xuehua F, Yawei X, Liqiong H. Cardiac Shock Wave Therapy Ameliorates Myocardial Ischemia in Patients With Chronic Refractory Angina Pectoris: A Randomized Trial. Front Cardiovasc Med. 2021 Jul 21;8:664433. doi: 10.3389/fcvm.2021.664433. eCollection 2021.

Reference Type DERIVED
PMID: 34368242 (View on PubMed)

Other Identifiers

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CSWT

Identifier Type: -

Identifier Source: org_study_id

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