- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078814
The Prevalence Survey of ALDH Gene Family in Patients With Peripheral Arterial Occlusive Disease or Acute Coronary Syndrome
October 1, 2021 updated by: Wei-Ting Chang, Chimei Medical Center
Aldehyde dehydrogenase 2 (ALDH2) is an important enzyme protecting human from the accumulation of aldehyde, the main metabolites of alcohol.
The deficiency of ALDH2 gene results in flush and hang over post drinking and most importantly it has been found associated with the incidence of cancer and post myocardial infarction (MI) heart failure.
In the previous studies, ALDH2 decreased the ischemic territory post infarction and using a large scaled interaction of genetic variants and ALDH2 as an instrument, the threats of alcohol consumption on Asians' cardiovascular health was underscored.
Furthermore, in a meta-analysis reviewing 12 case-control studies also indicated an increase of 48% risks in patients with ALDH2 deficiency.
Notably, the genetic deficiency is most prevalent in Asians.
In Taiwan one of every two individuals may be the victim and the high prevalence is counted as the top of the world.
However, a large scaled prospective study focusing on the prevalence of ALDH2 deficiency in patients with peripheral artery occlusive disease (PAOD) or acute coronary syndrome (ACS)remains lacking.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wei-Ting Chang
- Phone Number: 57332 +886-6-2812811
- Email: cmcvecho2@gmail.com
Study Locations
-
-
-
Tainan, Taiwan
- Recruiting
- Wei-Ting Chang
-
Contact:
- Wei-Ting Chang
- Phone Number: 57332 +886-6-2812811
- Email: cmcvecho2@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Diagnosed as peripheral arterial obstruction or acute coronary syndrome.
Description
Inclusion Criteria:
- Age≧20 y/o
- Using ankle-brachial index (ABI)< 0.9, angiography, vascular duplex, CAT scan or cardiologists'impression to confirm the diagnosis of PAOD
- Clinical presentation of claudication
- diagnosis of ACS
Exclusion Criteria:
- If the patient refuses to be included in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The incidence of MALE(major adverse limb events) in peripheral arterial disease and acute coronary disease.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The incidence of MACCE(major adverse cardiac and cerebrovascular events) in peripheral arterial disease and acute coronary disease.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Anticipated)
December 31, 2026
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
September 6, 2021
First Submitted That Met QC Criteria
October 1, 2021
First Posted (Actual)
October 15, 2021
Study Record Updates
Last Update Posted (Actual)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 1, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMMC10705-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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