MedDataX Logo

Relationship Between ALDH2 and CIN

NCT ID: NCT02643706

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this clinical trial is to investigate the relationship between the gene polymorphism of aldehyde dehydrogenase 2 and contrast induced nephropathy and its mechanism.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients undergoing coronary angiography or percutaneous coronary intervention will be recruited in this study after they sign the informed consent.5ml venous blood was extracted from the peripheral vein before the operation to detect the renal function, the genotype and enzyme activity of aldehyde dehydrogenase 2 ,and the levels of oxidative stress and inflammation.Another 5ml venous blood was extracted from the peripheral vein 24-72 hours after the operation to detect the renal function and the levels of oxidative stress and inflammation.Activated oxygen protein products , 4-HNE and hs-CRP as markers for oxidative stress and inflammation.The renal function index contains serum creatinine，urea nitrogen and cystatin C.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Radiographic Contrast Agent Nephropathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Aldehyde dehydrogenase 2 contrast induced nephropathy Gene polymorphism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CIN

CIN was defined as an absolute increase in serum creatinine concentration of at least 0.5 mg/dL (44.2umol/l) or a relative rise of at least 25% from baseline on the follow-up blood sample drawn 24 to 72 hours after the operation.

No interventions assigned to this group

Control

The enrolled patients without CIN.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing elective coronary intervention or coronary angiography at Yu Qilu hospital.
* All the patients or their guardians must sign the consent form before entering the trial.

Exclusion Criteria

* Patients with acute renal failure, renal transplantation, end-stage renal disease, or dialysis treatment, GFR \< 15ml/min.
* Use of renal toxicity drugs during the treatment, such as non steroidal anti-inflammatory drugs, etc.
* Patients who has used contrast agent 10 days before the operation.
* Cardiac shock, hypotension (systolic blood pressure \< 95mmHg),or hyper- tension with difficulty to control.
* Allergy to contrast media.
* Congestive heart failure (left ventricular ejection fraction\<40%), cardiac function NYHA grade IV.
* Pregnancy or lactation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Feng Xu

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Feng Xu

Role: CONTACT

Phone: 18560083066

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Feng Xu, M.D., Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Qiluexcellentyouth

Identifier Type: -

Identifier Source: org_study_id