NCT05508269

Brief Summary

Background:Ischemic heart disease is one of the heaviest health-related burdens worldwide.We aimed to identify the common hub mRNA and pathways that are involved in pathological progression of ischemic cardiomyopathy. Methods: To explore potential differentially expressed genes (DEGs) of all ischemic heart disease stages, we used chipster and GEO2R tools to analyze of retrieved eight high throughput RNA datasets obtained from GEO database. Gene Ontology functional annotation and Pathways enrichment analyses were used to obtain the common functional enriched DEGs which were visualized in protein-protein interactions (PPI) network to explore the hub mRNA according to the interaction scores. Validation qRT-PCR was carried out for blood and cardiac biopsies compared with controls to validate the determined four hub mRNAs and subsequently reviewed inside comprehensive published meta-analysis database. The validated mRNAs were visualized in two interaction modules. Finally screening of approved drugs was applied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

September 13, 2019

Last Update Submit

January 24, 2023

Conditions

Keywords

Ischemic Cardiomyopathyqrt-pcr

Outcome Measures

Primary Outcomes (1)

  • Genetic pathway of pathological progression from stable coronary artery disease to myocardial infarction and finally to ischaemic cardiomyopathy

    The expected results may explain novel genetic pathways of the clinical progression of asymptomatic structural cardiac disorder (Stable coronary artery disease) to typically symptomatic ischaemic cardiomyopathy. Gene expression profiling of seven genes in RNA of all cardiac specimens was measured using QPCR analysis.

    2 years

Study Arms (4)

Control subjects

control cases who were diagonosed as healthy subjects after diagnostic catheterization

Genetic: quantitative polymerase chain reaction(QPCR) for four genesProcedure: Cardiac biopsy, blood sampling

Stable coronary artery disease

patients with stable coronary artery disease undergoing elective PCI who were diagnozed with coronary lesion/s and underwent stent implantation without previous history of myocardial infarction

Genetic: quantitative polymerase chain reaction(QPCR) for four genesProcedure: Cardiac biopsy, blood sampling

Myocardial infarction patients

patients with history of myocardial infarction or with acute myocardial infarction undergoing primary PCI

Genetic: quantitative polymerase chain reaction(QPCR) for four genesProcedure: Cardiac biopsy, blood sampling

Ischaemic cardiomyopathy patients

patients with ischaemic cardiomyopathy diagnosed by ejection fraction less than 35% with history of coronary artery disease or myocardial infarction or those with acute myocardial infarction with reduced ejection fraction.

Genetic: quantitative polymerase chain reaction(QPCR) for four genesProcedure: Cardiac biopsy, blood sampling

Interventions

quantitative polymerase chain reaction(QPCR) for four genes

Control subjectsIschaemic cardiomyopathy patientsMyocardial infarction patientsStable coronary artery disease

In the studied thirteen peripheral blood subjects, five milliliters blood samples were taken from each patient in potassium EDTA tubes, immediately inserted in liquid nitrogen container and then stored in -80 refrigerators. All studied thirteen cardiac tissue subjects were underwent cardiac biopsy after PCI in order to take two specimens from the left ventricle using judkin right seven french catheters for femoral access and cardiac bioptome 2.3 mm wide. All cardiac specimens were collected in cryotubes, immediately inserted in liquid nitrogen container and then stored in -80 refrigerators.

Control subjectsIschaemic cardiomyopathy patientsMyocardial infarction patientsStable coronary artery disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study subjects were categorized into three control cases who were diagonosed as healthy subjects after diagnostic catheterization, three patients with stable coronary artery disease undergoing elective PCI who were diagnozed with coronary lesion/s and underwent stent implantation without previous history of myocardial infarction, four patients with history of myocardial infarction or with acute myocardial infarction undergoing primary PCI and three patients with ischaemic cardiomyopathy diagnosed by ejection fraction less than 35% with history of coronary artery disease or myocardial infarction or those with acute myocardial infarction with reduced ejection fraction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

cardiology hospital (Asyut University, Asyut, Egypt)

Asyut, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cardiac tissue specimens and blood specimens

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Mina Wageh Mohareb, Clinical researcher, Faculty of Pharmacy, Cairo University

Study Record Dates

First Submitted

September 13, 2019

First Posted

August 19, 2022

Study Start

April 1, 2021

Primary Completion

August 17, 2022

Study Completion

August 17, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations