Association Study to Evaluate TFPI Gene in CAD in Han Chinese

Coronary Heart Disease Clinical Trial

Official title:

Association Study to Evaluate TFPI Gene in CAD in Han Chinese

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02961127
• Other study ID #: 2013-2-5
• Status: Not yet recruiting
• Phase: N/A
• First received: November 6, 2016
• Last updated: November 8, 2016
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: November 2016
• Source: Chinese PLA General Hospital
• Contact: Yundai Chen, Ph D
• Phone: +86 531-51666045
• Email: ydchen301[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial 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.

Description:

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Venous blood was collected
Venous blood was collected by standard vein puncture in fasting condition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No