UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053786 |
|---|---|
| Receipt number | R000061387 |
| Scientific Title | Prospective observational study to assess the change in Achilles tendon thickness among patients undergoing PCI: Achilles Study. |
| Date of disclosure of the study information | 2024/03/06 |
| Last modified on | 2024/03/06 09:51:24 |
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Basic information
Public title
Prospective observational study to assess the change in Achilles tendon thickness among patients undergoing PCI: Achilles Study.
Acronym
Achilles Study
Scientific Title
Prospective observational study to assess the change in Achilles tendon thickness among patients undergoing PCI: Achilles Study.
Scientific Title:Acronym
Achilles Study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with ischemic heart disease who underwent PCI, we will evaluate Achilles tendon thickness using ultrasound imaging and investigate changes in Achilles tendon thickness after optimal medical therapy, including lipid-lowering therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Achilles tendon thickness measured by ultrasound from baseline to 1 year.
Key secondary outcomes
Association between Achilles tendon thickness and following variables: coronary artery disease severity by angiography, coronary plaque volume by CTA, carotid plaque by carotid ultrasound, ABI, and CAVI.
Change in the following variables from baseline to 1 year: coronary artery disease severity by angiography, coronary plaque volume by CTA, carotid plaque by carotid ultrasound, ABI, and CAVI.
Clinical events at 1, 2, 3, 4, and 5 years.
-all-cause death
-cardiovascular death
-non-cardiovascular death
-myocardial infarction
-stroke
-revascularization
-stent thrombosis
-bleeding
-restenosis
-coronary stenosis progression
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent percutaneous coronary intervention for ischemic heart disease.
Key exclusion criteria
Patients who are under 20 years old. Patients judged by the principal investigator to be inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Oyama |
Organization
Ina Central Hospital
Division name
Cardiovascular Medicine
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina, Nagano, Japan.
TEL
0265-72-3121
yushioyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Oyama |
Organization
Ina Central Hospital
Division name
Cardiovascular Medicine
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina, Nagano, Japan.
TEL
0265-72-3121
Homepage URL
yushioyama@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Ina Central Hospital
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
Ina Central Hospital ethics committee
Address
1313-1 Koshiroukubo, Ina, Nagano, Japan.
Tel
0265-72-3121
mn15436@inahp.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 | 03 | Month | 06 | 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
| 2023 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients will be followed up to 5 years.
Management information
Registered date
| 2024 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061387
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
