NCT05078814

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2018Dec 2026

Study Start

First participant enrolled

March 1, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 15, 2021

Status Verified

September 1, 2021

Enrollment Period

8.8 years

First QC Date

September 6, 2021

Last Update Submit

October 1, 2021

Conditions

Keywords

Peripheral Artery Occlusive Disease or Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • The incidence of MALE(major adverse limb events) in peripheral arterial disease and acute coronary disease.

    2 years

Secondary Outcomes (1)

  • The incidence of MACCE(major adverse cardiac and cerebrovascular events) in peripheral arterial disease and acute coronary disease.

    2 years

Interventions

Observational research

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diagnosed as peripheral arterial obstruction or acute coronary syndrome.

You may qualify if:

  • 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

You may not qualify if:

  • If the patient refuses to be included in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wei-Ting Chang

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

September 6, 2021

First Posted

October 15, 2021

Study Start

March 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 15, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations