Association Between Some Polymorphisms in Apelin/ Apelin Receptor Genes and Coronary Artery Disease in Syrian Patients

Sponsor

Damascus University (Other)

Overall Status

Completed

CT.gov ID

NCT05562687

Collaborator

(none)

230

Enrollment

Location

32.1

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The apelin-APJ signaling pathway has emerged as an important novel mediator of cardiovascular control and blood pressure homeostasis. Genetic variation in apelin and its receptors likely contributes to essential hypertension, in addition to a range of traditional risk factors. Thus, a study will be conducted on Syrian patients with hypertension and coronary artery disease to investigate some of the single polymorphisms in the apelin gene and its receptor that may be responsible for the development of these diseases, and to link the levels of this peptide and its receptor in the blood with these polymorphisms and the percentage of these diseases (as shown by many Modern Global Reference Studies).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Hypertension

Detailed Description

Blood levels of apelin and its receptor will be determined in patients and controls, and correlated with hypertension and coronary artery disease. And the allelic and genotypic frequencies of the G212A single polymorphism nucleotide of the apelin receptor gene and the -1860T>C single polymorphism nucleotide of the apelin gene in the study groups. And evaluation the functional role of A allele in hypertension. As well as investigating the association between: the genotypes of the apelin gene and the levels of apelin in the plasma, the genotypes of the apelin receptor gene and the levels of APJ in the plasma in the study groups. And link the polymorphism of the apelin gene with the polymorphism of the apelin receptor gene. And to determine the correlation between the presence of the studied SNPs and some traditional risk factors for coronary artery disease, which are age, hypertension, the onset age of hypertension, smoking, BMI, cholesterol and triglyceride levels in the blood, and family history of CAD.

Study Design

Study Type:

Observational

Actual Enrollment :

230 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Investigation of Association Between Single Nucleotide Polymorphisms in Genes of the Apelin/ APJ System (-1860T>C & G212A) and CAD Risk and Hypertension in Syrian Patients

Actual Study Start Date :

Dec 15, 2019

Actual Primary Completion Date :

Jan 5, 2022

Actual Study Completion Date :

Aug 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Control group subjects who do not have any heart disease, hypertension, or other chronic &inflammatory diseases, and their coronary arteries are normal
CAD group with essential hypertension subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have high blood pressure
CAD group without essential hypertension subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have normal blood pressure
Hypertension group without CAD the subjects were characterized by the normal coronary artery and high blood pressure

Outcome Measures

Primary Outcome Measures

Blood apelin concentrations [Collecting blood samples before angiography]
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1000 g for 10 min, then plasma specimens were stored at -80°C until analysis.
Blood apelin receptor (APJ) concentrations [Collecting blood samples before angiography]
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1000 g for 10 min, then plasma specimens were stored at -80°C until analysis
The allelic and genotypic frequencies of the -1860T>C single polymorphism nucleotides of the apelin genes [Collecting blood samples before angiography]
Genomic DNA will be extracted from peripheral blood sample, after that DNA will be stored in a deep freezer (-80°C) until the genetic analysis
The allelic and genotypic frequencies of the G212A single polymorphism nucleotides of the apelin receptor genes [Collecting blood samples before angiography]
Genomic DNA will be extracted from peripheral blood sample, after that DNA will be stored in a deep freezer (-80°C) until the genetic analysis.

Secondary Outcome Measures

BMI [before angiography]
measurement of body weight and height will be recorded to calculate the body mass index
Measurement of blood pressure [before angiography]
Hypertension was diagnosed when the average of three blood pressure readings was at least 140 mmHg systolic or 90 mmHg diastolic, or in the event the individuals were taking antihypertensive medication
Plasma levels of triglycerides (TG) [Collecting blood samples before angiography]
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1750 g for 10 min, then plasma specimens were stored at -80°C until analysis
total cholesterol (TC) levels in plasma [Collecting blood samples before angiography]
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1750 g for 10 min, then plasma specimens were stored at -80°C until analysis
high-density lipoprotein cholesterol (HDL-C) levels in plasma [Collecting blood samples before angiography]
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1750 g for 10 min, then plasma specimens were stored at -80°C until analysis
low-density lipoprotein cholesterol (LDL-C) [Collecting blood samples before angiography]
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1750 g for 10 min, then plasma specimens were stored at -80°C until analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 78 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Control group: the subjects were characterized by no history of angina and other heart disease or hypertension, and do not have other chronic or inflammatory diseases.

They represent a normal resting ECG and normal exercise ECG stress testing. And the angiography showed the absence of any stenosis of the coronary arteries.

They were matched with CAD patients according to age, gender and ethnicity.

CAD group with essential hypertension: the subjects were characterized by at least 70% stenosis in any coronary artery and high blood pressure (the average of three blood pressure readings was at least 140 mmHg systolic or 90 mmHg diastolic).
CAD group without essential hypertension: the subjects were characterized by at least 70% stenosis in any coronary artery and normal blood pressure.
Hypertension group without CAD: the subjects were characterized by the normal coronary artery and high blood pressure. And they were characterized by no history of angina and other heart disease or hypertension, and do not have other chronic or inflammatory diseases.