UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053856 |
|---|---|
| Receipt number | R000061470 |
| Scientific Title | Critical Limb Ischemia and Its Predictive Factors After Revascularization: A Single-Center Retrospective Study from A Resource-Limited Setting |
| Date of disclosure of the study information | 2024/03/14 |
| Last modified on | 2024/03/14 09:37:43 |
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Basic information
Public title
Critical Limb Ischemia and Its Predictive Factors After Revascularization: A Single-Center Retrospective Study from A Resource-Limited Setting
Acronym
Critical Limb Ischemia and Its Predictive Factors After Revascularization: A Single-Center Retrospective Study from A Resource-Limited Setting
Scientific Title
Critical Limb Ischemia and Its Predictive Factors After Revascularization: A Single-Center Retrospective Study from A Resource-Limited Setting
Scientific Title:Acronym
Critical Limb Ischemia and Its Predictive Factors After Revascularization: A Single-Center Retrospective Study from A Resource-Limited Setting
Region
| Asia(except Japan) |
Condition
Condition
Limb Ischemia
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study was to investigate the clinical presentation, treatment, and outcomes of surgical revascularization for Critical Limb Ischemia in a resource-limited setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of revascularization were assessed clinically, and hemodynamically by determination of ankle-brachial index (ABI) and anatomically using postoperative DUS. The composite endpoint of major amputation and/or death 30 days after surgery was defined as the main study outcome.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All consecutive patients presenting in vascular service of the Institute of Emergency Medicine (Sana'a, Yemen), diagnosed with ALI, and treated with urgent revascularization were enrolled. Patients with acute occlusion of native arteries, vascular reconstructions (autologous conduit, synthetic bypass, stent, or stent graft), and peripheral aneurysms were included.
Key exclusion criteria
Patients were excluded if they met any of the following criteria: (1) ALI caused by trauma (including iatrogenic injuries); (2) ALI associated with aortic dissection; (3) ALI as a complication of vascular interventions developed in the early postoperative period (during the same hospitalization); (4) acute onset of intermittent claudication.
Target sample size
91
Research contact person
Name of lead principal investigator
| 1st name | Faisal |
| Middle name | Mohammed |
| Last name | Ahmed |
Organization
Ibb University
Division name
Department of Surgery
Zip code
PO Box 70270
Address
Al-Thora General Hospital, Department of Urology, School of Medicine, Ibb University of Medical Sciences, Ibb, Yemen.
TEL
+967776089579
fmaaa2006@yahoo.com
Public contact
Name of contact person
| 1st name | Faisal |
| Middle name | Mohammed |
| Last name | Ahmed |
Organization
Ibb University
Division name
Department of Surgery
Zip code
PO Box 70270
Address
Department of General Surgery, School of Medicine, Ibb University of Medical Sciences, Ibb, Yemen.
TEL
+967776089579
Homepage URL
qalyhary@hotmail.com
Sponsor or person
Institute
Ibb University
Institute
Department
Personal name
Funding Source
Organization
Ibb university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibb University
Address
Al-Thora General Hospital, Department of Urology, School of Medicine, Ibb University of Medical Sciences, Ibb, Yemen.
Tel
009674416416
fmaaa2006@yahoo.com
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 | 14 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center retrospective study included 91 patients with ALI treated with urgent revascularization between June 2019 and December 2022 at Al-Thora General Hospital, Sana'a, Yemen. The study protocol was prepared following the principles of the Declaration of Helsinki and approved by the Ethics Committee of Al-Thora General Hospital (Sana'a, Yemen). Due to the anonymous retrospective nature of the study, written informed consent from the included patients was not required.
ALI was defined as a sudden onset of circulatory deficiency in the upper or lower extremities that endangers their viability and does not last longer than 14 days.
Data gathering:
Demographic characteristics and comorbidities; clinical, imaging, and laboratory data relevant to the diagnosis and severity of ALI details of revascularization procedure, antithrombotic treatment, and complications were collected from the patient's medical profiles.
Study Outcomes:
Revascularization results were assessed clinically, and hemodynamically by determination of ankle-brachial index (ABI) and anatomically using postoperative DUS. The composite endpoint of major amputation and/or death 30 days after surgery was defined as the main study outcome. The postoperative ABI value, reinterventions, complications, and length of hospital stay were considered secondary outcomes.
Management information
Registered date
| 2024 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061470
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