NCT03398096

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable coronary-artery-disease

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

First Submitted

Initial submission to the registry

December 14, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

December 14, 2017

Last Update Submit

January 7, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

  • Canadian Cardiovascular Society (CCS) grading of angina

    questionnaire of Canadian Cardiovascular Society grading of angina concerning exercise tolerance

    6 months

  • Seattle angina questions (SAQ)

    questionnaire of Seattle angina questions to evaluate the effect of coronary artery disease on patients' life quality

    6 months

  • 6-min walk test

    All participants will receive a 6 minutes' walk test to evaluate their effect of treatment of cardiac shock wave therapy

    6 months

  • Nitrate consumption

    All participants will receive a questionnaire of the amount of nitrate they need before and after treatment of cardiac shock wave therapy

    6 months

Study Arms (2)

Cardiac shock wave therapy (CSWT) group

EXPERIMENTAL

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.

Device: Cardiac shock wave therapy

Control group

NO INTERVENTION

No CWST treatment.

Interventions

Cardiac shock wave therapyDEVICE

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.

Cardiac shock wave therapy (CSWT) group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • AMI、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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

  • 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.

    PMID: 34368242DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Weijing Liu

CONTACT

18917684041liuweijing98@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2017

First Posted

January 12, 2018

Study Start

March 30, 2018

Primary Completion

June 30, 2018

Study Completion

September 30, 2018

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

CN(1)