Peripheral Artery Occlusive DiseaseNCT05078814
The Prevalence Survey of ALDH Gene Family in Patients With Peripheral Arterial Occlusive Disease or Acute Coronary Syndrome
An observational study of Peripheral Artery Occlusive Disease and Acute Coronary Syndrome, run by Chimei Medical Center at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Artery Occlusive Disease, Acute Coronary Syndrome
- What is being tested?
- Observational research
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2018to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed as peripheral arterial obstruction or acute coronary syndrome.
Who may be able to join
- 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
Who cannot join
- If the patient refuses to be included in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Wei-Ting Chang
Tainan
Wei-Ting Chang, +886-6-2812811 ext. 57332, cmcvecho2@gmail.com
About this study
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.
- Being tested
- Observational research
- Keywords
- Peripheral Artery Occlusive Disease or Acute Coronary Syndrome
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational researchOther
Observational research
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of MALE(major adverse limb events) in peripheral arterial disease and acute coronary disease.
Measured: 2 years
Secondary outcomes (1)
The incidence of MACCE(major adverse cardiac and cerebrovascular events) in peripheral arterial disease and acute coronary disease.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Mar 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Ting Chang, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078814
- Sponsor's protocol ID
- CMMC10705-003
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No