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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014562
Receipt No. R000016756
Scientific Title Low-energy extracorporeal cardiac shock wave therapy in patients with acute myocardial infarction
Date of disclosure of the study information 2014/07/15
Last modified on 2016/07/15

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Basic information
Public title Low-energy extracorporeal cardiac shock wave therapy in patients with acute myocardial infarction
Acronym Shock wave therapy for AMI
Scientific Title Low-energy extracorporeal cardiac shock wave therapy in patients with acute myocardial infarction
Scientific Title:Acronym Shock wave therapy for AMI
Region
Japan

Condition
Condition Acute myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To suppress left ventricular (LV) remodeling after acute myocardial infarction (AMI)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LV volume and LV ejection fraction at 6 months and 12 months after AMI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Low-energy extracorporeal cardiac shock wave therapy (3 times in the first week. 30 or less spots around infarcted area, 200 shots/spot each time)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) 20-79 year-old men, 20-74-year-old women.
2) Reperfusion therapy is succeeded with no distal emboli.
3) Therapy can be started within 72 hours after the onset of AMI.
4) The peak CK in serum is 4000 U/L or less.
Key exclusion criteria 1) Patients with cardiogenic shock or congestive heart failure (who require continuous infusion of cardiovascular agents such as inotropic agents or vasodilators).
2) Patients with severe arrhythmia requiring a cardioversion procedure after PCI.
3) Broad anterior AMI.
4) Patients whose target area cannot be observed with echocardiography.
5) Post-breast augmentation surgery with silicon pad.
6) Intracardiac thrombus.
7) Patients who have malignancy or who have undergone surgery because of malignancy within the past five years.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
TEL 022-717-7153
Email cswt@cardio.med.tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kenta Ito
Organization Tohoku University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
TEL 022-717-7153
Homepage URL
Email cswt@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2006 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 15 Day
Last modified on
2016 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016756

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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