Association Study to Evaluate TFPI Gene in CAD in Han Chinese

NCT02961127 | Unknown DMC

• 1 other identifier: 2013-2-5
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The cases were hospitalized patients from two medical centers in Beijing and Harbin respectively. Venous blood was collected by standard vein puncture in fasting condition.

Conditions

Coronary Heart Disease

Keywords

tissue factor pathway inhibitor

Outcome Measures

Primary Outcomes (1)

• the frequencies of TFPI were associated with CAD in Han Chinese

  Four single-nucleotide polymorphisms (SNPs) (rs7586970, rs6434222, rs10153820 and rs8176528) were detected with polymerase chain reaction-direct sequencing methods.And the genotypes of these SNPs were determined in both CAD patients and non-CAD controls.

  1 year

Study Arms (2)

group 1

no drugs were used in our study

Other: Venous blood was collected

group 2

Other: Venous blood was collected

Interventions

Venous blood was collected OTHER

Venous blood was collected by standard vein puncture in fasting condition

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cases were all hospitalized patients recruited from two medical centers in Beijing and Harbin. The participants with two or more risk factors of CAD (age\>45 for man and \>55 for woman, hypertension, diabetes, overweight, hyperlipidemia) were subjected to treadmill stress test and selected as controls if their ECG were normal without clinical symptoms.

You may qualify if:

• The coronary artery disease was defined by one of the following criteria-(1) based on World Health Organization criteria in terms of elevations of cardiac enzymes, electrocardiography (ECG) and clinical symptoms (angina, chest pressure, or shortness of breath); (2) angiographic evidence of more than 50% stenosis in one or more major coronary arteries; (3) previous history of PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft).
• The controls were selected from the two medical centers meeting the following criteria: (1) with no family history for CAD; (2) no clinical symptoms for CAD; (3) resting ECG showed normal results. The subjects with two or more risk factors of CAD (age\>45 for man and \>55 for woman, hypertension, diabetes, overweight, hyperlipidemia) were subjected to treadmill stress test and selected as controls if their ECG were normal without clinical symptoms.

You may not qualify if:

• Those with history of cardiomyopathy, valvular disease, peripheral vascular disease, stroke, severe hepatic and kidney deficiency were excluded in our study.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood was collected by standard vein puncture in fasting condition. Four single-nucleotide polymorphisms (SNPs) (rs7586970, rs6434222, rs10153820 and rs8176528) were detected with polymerase chain reaction-direct sequencing method. And the genotypes of these SNPs were determined in both CAD patients and non-CAD controls.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yundai Chen, Ph D

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Yundai Chen, Ph D

CONTACT

+86 531-51666045; ydchen301@163.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cardiology

Study Record Dates

• First Submitted: November 6, 2016
• First Posted: November 10, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 10, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share