UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041429 |
|---|---|
| Receipt number | R000047298 |
| Scientific Title | The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/08/16 |
| Last modified on | 2021/07/17 10:18:09 |
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Basic information
Public title
The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis
Acronym
The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis
Scientific Title
The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis
Scientific Title:Acronym
The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis
Region
| Asia(except Japan) |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform a systematic review and meta-analysis of published data to assess the relationship between contractile reserve (CR) and cardiac resynchronization therapy (CRT)-response.
Basic objectives2
Others
Basic objectives -Others
relationship to predict outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiac resynchronization therapy (CRT)-response
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. human studies with an adult sample indicated for CRT insertion according to heart failure guideline criteria.
2. CRT dan Stress Echocardiography were done in the sampe patient population.
3. availability of contractile reserve (CR) parameter data before and after CRT.
4. clear definition of response to CRT.
5. followed up for at least 6 months post CRT insertion.
Key exclusion criteria
1. focus on specific populations (CRT super-responders, post ICD insertion population, and patients with aortic stenosis or septal flash).
2. case report studies, case series, reviews, editorials, or conference papers.
3. missing required data.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Ivana |
| Middle name | Purnama |
| Last name | Dewi |
Organization
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name
Department of Cardiology and Vascular Medicine
Zip code
60131
Address
Jl. Mayjen Prof. Dr. Moestopo 47
TEL
6281328098200
916ivana@gmail.com
Public contact
Name of contact person
| 1st name | Eka |
| Middle name | Prasetya Budi |
| Last name | Mulia |
Organization
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name
Department of Cardiology and Vascular Medicine
Zip code
60131
Address
Jl. Mayjen Prof. Dr. Moestopo 47
TEL
628562765365
Homepage URL
https://www.researchgate.net/profile/Eka_Mulia
eka.prasetya.budi-2017@fk.unair.ac.id
Sponsor or person
Institute
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komite Etik Penelitian Kesehatan RSUD Dr Soetomo, Surabaya, Indonesia
Address
Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel
0315501011
kontak@rsudrsoetomo.jatimprov.go.id
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
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3889/oamjms.2021.5725
Number of participants that the trial has enrolled
1399
Results
We identified 17 studies involving 1399 patients. Presence of CR was associated with a higher chance of CRT response (OR 7.68) using a random-effects model.
Results date posted
| 2020 | Year | 10 | Month | 10 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 09 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
We perform a systematic review and meta-analysis of published data to assess the relationship between contractile reserve (CR) and CRT response.
We conduct a systematic search from major medical databases (PubMed, MEDLINE, Clinical Key, Cochrane Library, EMBASE). We search all clinical trials published up to June 2020, written in English, fulltext availability, and human subject. We used Newcastle Ottawa Scale (NOS) to measure the quality of evidence. We employed the Mantel Haenszel random effects meta-analysis of using RevMan 5.3
Management information
Registered date
| 2020 | Year | 08 | Month | 16 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047298
