UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055332 |
|---|---|
| Receipt number | R000063118 |
| Scientific Title | Effect of IMPELLA on coronary microcirculation in patients with left ventricular dysfunction and coronary artery disease (CoroPELLA study) |
| Date of disclosure of the study information | 2024/08/26 |
| Last modified on | 2024/08/25 22:40:44 |
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Basic information
Public title
Effect of IMPELLA on coronary microcirculation in patients with left ventricular dysfunction and coronary artery disease
Acronym
CoroPELLA study
Scientific Title
Effect of IMPELLA on coronary microcirculation in patients with left ventricular dysfunction and coronary artery disease (CoroPELLA study)
Scientific Title:Acronym
CoroPELLA study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of IMPELLA on coronary microcirculation in patients with left ventricular dysfunction and coronary artery disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in IMR (index of microvascular resistance) from baseline to maximum IMPELLA flow
Key secondary outcomes
Change in the following variables between time points A-F except for the primary outcome.
Variables: index of microvascular resistance (IMR), coronary flow reserve (CFR), fractional flow reserve (FFR), resistive reserve ratio (RRR), pressure-bounded CFR (PB-CFR), corrected IMR, CFR norm (CFR/FFR), mean transit time (rest), and mean transit time (hyperemia).
Timepoints: A, Baseline; B, Low IMPELLA flow (P2); C, Maximum IMPELLA flow; D, post-PCI maximum IMPELLA flow; E, post-PCI low IMPELLA flow (P2); F, After IMPELLA decannulation.
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing high-risk percutaneous coronary intervention (fulfilling one of the following clinical and/or anatomical high-risk criteria: clinical characteristics [left ventricular ejection fraction <35%, hemodynamic instability, diabetes mellitus, acute coronary syndromes, previous cardiac surgery, chronic kidney disease], angiographic characteristics [diffuse coronary artery disease, multivessel disease, unprotected left main coronary disease involving bifurcation, severely calcified lesions needing rotational atherectomy, last patent conduit]) with hemodynamic support by IMPELLA.
Key exclusion criteria
Congenital heart disease, cardiac shunt, coronary vessels with chronic total occlusion (CTO), or donor arteries of the CTO lesions.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ueki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
3908621
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
81-263-37-3486
yasushi522@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Department of Cardiovascular Medicine
Division name
Department of Cardiovascular Medicine
Zip code
3908621
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
81-263-37-3486
Homepage URL
jersey0042@gmail.com
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Institutional Review Board
Address
3-1-1 Asahi, Matsumoto, Japan
Tel
81-263-37-2572
mdrinri@shinshu-u.ac.jp
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
| 2024 | Year | 08 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 08 | Month | 25 | Day |
Last modified on
| 2024 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063118
