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

May 5, 2024 updated by: Damascus University

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, 011
        • Damascus University- Faculty of Pharmacy- Research and Graduate Studies Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

  • 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.

Description

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.

Exclusion Criteria:

  • Individuals with valvular heart disease, cardiomyopathy, chronic kidney disease, diabetes, and inflammatory disease were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood apelin concentrations
Time Frame: 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.
Collecting blood samples before angiography
Blood apelin receptor (APJ) concentrations
Time Frame: 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
Collecting blood samples before angiography
The allelic and genotypic frequencies of the -1860T>C single polymorphism nucleotides of the apelin genes
Time Frame: 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
Collecting blood samples before angiography
The allelic and genotypic frequencies of the G212A single polymorphism nucleotides of the apelin receptor genes
Time Frame: 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.
Collecting blood samples before angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: before angiography
measurement of body weight and height will be recorded to calculate the body mass index
before angiography
Measurement of blood pressure
Time Frame: 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
before angiography
Plasma levels of triglycerides (TG)
Time Frame: Collecting blood samples before angiography
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 3000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Collecting blood samples before angiography
total cholesterol (TC) levels in plasma
Time Frame: Collecting blood samples before angiography
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 3000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Collecting blood samples before angiography
high-density lipoprotein cholesterol (HDL-C) levels in plasma
Time Frame: Collecting blood samples before angiography
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 3000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Collecting blood samples before angiography
low-density lipoprotein cholesterol (LDL-C)
Time Frame: Collecting blood samples before angiography
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 3000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Collecting blood samples before angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Director: Hussam Shebli, PhD, Damascus university, ASPU Al-Sham Private University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2019

Primary Completion (Actual)

January 5, 2022

Study Completion (Actual)

August 18, 2022

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDFP-Chemical-02-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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