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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05078814
Other study ID # CMMC10705-003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date December 31, 2026

Study information

Verified date September 2021
Source Chimei Medical Center
Contact Wei-Ting Chang
Phone +886-6-2812811
Email cmcvecho2@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Age?20 y/o 2. Using ankle-brachial index (ABI)< 0.9, angiography, vascular duplex, CAT scan or cardiologists'impression to confirm the diagnosis of PAOD 3. Clinical presentation of claudication 4. diagnosis of ACS Exclusion Criteria: - If the patient refuses to be included in this study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational research
Observational research

Locations

Country Name City State
Taiwan Wei-Ting Chang Tainan

Sponsors (1)

Lead Sponsor Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of MALE(major adverse limb events) in peripheral arterial disease and acute coronary disease. 2 years
Secondary The incidence of MACCE(major adverse cardiac and cerebrovascular events) in peripheral arterial disease and acute coronary disease. 2 years
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