Acute Coronary SyndromeNCT04900545
Effect of Genetic Polymorphisms on Response to Beta Blocker Therapy in Egyptian Patients
An observational study of Acute Coronary Syndrome and Hypertension, run by Mohamed Saleh Fayed at 1 site in Egypt.
Trial summary
Beta-blockers represent a cornerstone for the treatment of coronary artery disease (CAD). Their protective effect is based on the negative inotropic and chronotropic features, which have been tested in a large number of randomized controlled trials, both in patients with myocardial infarction (MI) and in those with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Hypertension
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2021to 1 Aug 2021
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Beta-Blocker naive Egyptian patient with acute coronary syndrome.
Who may be able to join
- Beta-blockers naïve patients
- Patients been on beta-blocker therapy for at least 4 weeks.
- Age (18-75) Years old.
Who cannot join
- Non-Egyptians.
- Kidney failure of any stage.
- Liver failure of any stage.
- Malignancy.
- Pregnancy.
- HR < 55 beats/min (in the absence of b-blocker therapy).
- Presence of a cardiac pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Beta-blockers represent a cornerstone for the treatment of coronary artery disease (CAD). Their protective effect is based on the negative inotropic and chronotropic features, which have been tested in a large number of randomized controlled trials, both in patients with myocardial infarction (MI) and in those with stable angina, demonstrating a reduction of adverse cardiovascular events, a relief of symptoms and a reduction of myocardial ischemia
However, considerable interpatient variability in response to β-blockers has been reported which indicates that a considerable proportion of β-blocker-treated patients do not achieve the warranted cardio protection with β- blockers. This highlights the importance of identifying biomarkers associated with variability in response to β-blockers to improve the current approach for β- blocker selection, which seems to be suboptimal.
This study aims to study the effect of polymorphism in adrenergic beta receptors on beta-blocker response in Egyptian patients.
- Conditions
- Acute Coronary Syndrome, Hypertension
- Medical subject headings
- Acute Coronary Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| beta blocker navie patients with acute coronary syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenergic receptors genes and blood pressure response to beta-blocker
Investigate the association of the adrenergic receptor polymorphisms with reduction in blood pressure (expressed in units of millimeters of mercury "mmHg" ) in the Egyptian patients with acute coronary syndrome on beta blocker therapy.
Measured: Three months
Adrenergic receptors genes and heart rate response to beta-blocker
Investigate the association of the adrenergic receptor polymorphisms with reduction in heart rate (expressed as beats per minute "BPM" ) in the Egyptian patients with acute coronary syndrome on beta blocker therapy.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start5 May 2021
- Primary completion25 May 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Saleh Fayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Saleh Fayed, Ain Shams University
- Investigators
- Nagwa A Sabry, PhD, Study chair, Ains Shams universityMohamed A Saleh, PhD, Study director, Ain Shams UniversityAmal A EL-Kholy, PhD, Study director, Ain Shams UniversityMohamed S Fayed, Bsc, Principal investigator, Ains Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900545
- Sponsor's protocol ID
- PHCL135
- Status last verified
- Nov 2022
- First submitted
- 20 May 2021
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genetic Polymorphisms on Response to Beta Blocker Therapy in Egyptian Patients
- ClinicalTrials.gov ID
- NCT04900545
- Acronym / sponsor ID
- PHCL135
- Conditions
- Acute Coronary Syndrome, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mohamed Saleh FayedUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 25 May 2021 (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.
Beta-blockers represent a cornerstone for the treatment of coronary artery disease (CAD). Their protective effect is based on the negative inotropic and chronotropic features, which have been tested in a large number of randomized controlled trials, both in patients with myocardial infarction (MI) and in those with stable angina, demonstrating a reduction of adverse cardiovascular events, a relief of symptoms and a reduction of myocardial ischemia
However, considerable interpatient variability in response to β-blockers has been reported which indicates that a considerable proportion of β-blocker-treated patients do not achieve the warranted cardio protection with β- blockers. This highlights the importance of identifying biomarkers associated with variability in response to β-blockers to improve the current approach for β- blocker selection, which seems to be suboptimal.
This study aims to study the effect of polymorphism in adrenergic beta receptors on beta-blocker response in Egyptian patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| beta blocker navie patients with acute coronary syndrome | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Beta-Blocker naive Egyptian patient with acute coronary syndrome.
Key inclusion criteria (3 listed)
- Beta-blockers naïve patients
- Patients been on beta-blocker therapy for at least 4 weeks.
- Age (18-75) Years old.
Key exclusion criteria (7 listed)
- Non-Egyptians.
- Kidney failure of any stage.
- Liver failure of any stage.
- Malignancy.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adrenergic receptors genes and blood pressure response to beta-blocker
Time frame: Three months
Investigate the association of the adrenergic receptor polymorphisms with reduction in blood pressure (expressed in units of millimeters of mercury "mmHg" ) in the Egyptian patients with acute coronary syndrome on beta blocker therapy.
Adrenergic receptors genes and heart rate response to beta-blocker
Time frame: Three months
Investigate the association of the adrenergic receptor polymorphisms with reduction in heart rate (expressed as beats per minute "BPM" ) in the Egyptian patients with acute coronary syndrome on beta blocker therapy.
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 1 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Nagwa A Sabry, PhD study chair
Ains Shams university
Mohamed A Saleh, PhD study director
Ain Shams University
Amal A EL-Kholy, PhD study director
Ain Shams University
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 Acute Coronary Syndrome and Hypertension, run by Mohamed Saleh Fayed 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?
The sponsor lists 3 inclusion and 7 exclusion criteria. 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 1 Dec 2022. 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?
Adrenergic receptors genes and blood pressure response to beta-blocker (time frame: Three months). The study lists 2 primary outcomes in all. 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 1 Dec 2022.