Ischemic CardiomyopathyNCT05508269
Genetics of Ischemic Cardiomyopathy
An observational study of Ischemic Cardiomyopathy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- quantitative polymerase chain reaction(QPCR) for four genes and Cardiac biopsy, blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 17 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Inclusion criteria The enrolled patients aged 20-80 years with stable coronary artery disease undergoing elective PCI or patients with unstable angina or myocardial infarction undergoing rescue PCI and admitted to the cardiology hospital (Asyut University, Asyut, Egypt) were recruited in this study.
Exclusion criteria Patients with dilated cardiomyopathy were execluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Polymerase Chain Reaction of Four Genes in Coronary Artery Disease, Myocardial Infarction and Ischemic Cardiomyopathy
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.
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- quantitative polymerase chain reaction(QPCR) for four genes, Cardiac biopsy, blood sampling
- Keywords
- Ischemic Cardiomyopathy, qrt-pcr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantitative polymerase chain reaction(QPCR) for four genesGenetic
quantitative polymerase chain reaction(QPCR) for four genes
Cardiac biopsy, blood samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control subjects | control cases who were diagonosed as healthy subjects after diagnostic catheterization Receives: Genetic: quantitative polymerase chain reaction(QPCR) for four genes; Procedure: 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 Receives: Genetic: quantitative polymerase chain reaction(QPCR) for four genes; Procedure: Cardiac biopsy, blood sampling | |
| Myocardial infarction patients | patients with history of myocardial infarction or with acute myocardial infarction undergoing primary PCI Receives: Genetic: quantitative polymerase chain reaction(QPCR) for four genes; Procedure: 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. Receives: Genetic: quantitative polymerase chain reaction(QPCR) for four genes; Procedure: Cardiac biopsy, blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Apr 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Wageh Mohareb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508269
- Sponsor's protocol ID
- RHFCS1
- Status last verified
- Jan 2023
- First submitted
- 13 Sep 2019
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Polymerase Chain Reaction of Four Genes in Coronary Artery Disease, Myocardial Infarction and Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05508269
- Acronym / sponsor ID
- RHFCS1
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- Ischemic Cardiomyopathy, qrt-pcr
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control subjects | – | Genetic: quantitative polymerase chain reaction(QPCR) for four genes, Procedure: Cardiac biopsy, blood samplingcontrol cases who were diagonosed as healthy subjects after diagnostic catheterization |
| Stable coronary artery disease | – | Genetic: quantitative polymerase chain reaction(QPCR) for four genes, Procedure: Cardiac biopsy, blood samplingpatients 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 |
| Myocardial infarction patients | – | Genetic: quantitative polymerase chain reaction(QPCR) for four genes, Procedure: Cardiac biopsy, blood samplingpatients with history of myocardial infarction or with acute myocardial infarction undergoing primary PCI |
| Ischaemic cardiomyopathy patients | – | Genetic: quantitative polymerase chain reaction(QPCR) for four genes, Procedure: Cardiac biopsy, blood samplingpatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quantitative polymerase chain reaction(QPCR) for four genesquantitative polymerase chain reaction(QPCR) for four genes | Genetic | Control subjects, Ischaemic cardiomyopathy patients, Myocardial infarction patients, Stable coronary artery disease |
| Cardiac biopsy, blood samplingIn 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. | Procedure or surgery | Control subjects, Ischaemic cardiomyopathy patients, Myocardial infarction patients, Stable coronary artery disease |
Primary outcome
Genetic pathway of pathological progression from stable coronary artery disease to myocardial infarction and finally to ischaemic cardiomyopathy
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiomyopathy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic pathway of pathological progression from stable coronary artery disease to myocardial infarction and finally to ischaemic cardiomyopathy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.