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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence Survey of ALDH Gene Family in Patients With Peripheral Arterial Occlusive Disease or Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05078814
- Acronym / sponsor ID
- CMMC10705-003
- Keywords
- Peripheral Artery Occlusive Disease or Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed as peripheral arterial obstruction or acute coronary syndrome.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- If the patient refuses to be included in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational researchObservational research | Other | – |
Primary outcome
The incidence of MALE(major adverse limb events) in peripheral arterial disease and acute coronary disease.
Time frame: 2 years
1 secondary outcome
The incidence of MACCE(major adverse cardiac and cerebrovascular events) in peripheral arterial disease and acute coronary disease.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Occlusive Disease and Acute Coronary Syndrome, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Ting Chang (+886-6-2812811 ext. 57332, cmcvecho2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of MALE(major adverse limb events) in peripheral arterial disease and acute coronary disease. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.