Coronary Artery EctasiaNCT05106530
Arrhythmogenic Risk Assessment in Coronary Artery Ectasia Patients
An observational study of Coronary Artery Ectasia, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators thought to explore arrhythmias outcome - hidden arrhythmias, ECG features: Tp-Te interval and Tp-Te/QTc ratio, fQRS among patients with coronary artery ectasia as compared to normal coronary artery patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Ectasia
- What is being tested?
- Holter, ECG
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jan 2023
- How long will I take part?
- 1 Day
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include consecutive eligible patients recruited in Assiut University Heart Hospital
Who may be able to join
- Subjects with suspected CAD who are referred for elective coronary angiography and/or interventions
Who cannot join
- Patients with a history of cardiomyopathy and myocardial infarction (MI), left ventricular hypertrophy (LVH), pathological Q wave on ECG, typical left bundle block or right bundle block, incomplete right bundle block, or paced rhythm on ECG.
- Patients with severe renal impairment
- Post CABG patients
- Patients of acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The investigators thought to explore arrhythmias outcome - hidden arrhythmias, ECG features: Tp-Te interval and Tp-Te/QTc ratio, fQRS among patients with coronary artery ectasia as compared to normal coronary artery patients.
Read the detailed description
All patients will be subjected to:
- Full history taking:
- Including age, sex, history of DM, HTN, dyslipidemia and Body surface area.
- Holter monitoring for 24 hours:
- Heart rate variability
- Hidden arrhythmias
- Hidden ischemia by monitoring ST segment changes
- Twelve lead ECG:
- fQRS in baseline ECG
- QT dispersion.
- Tp-Te interval and Tp-Te/QTc ratio
- Tp-Te dispersion
- Conditions
- Coronary Artery Ectasia
- Being tested
- Holter, ECG
- Keywords
- Coronary artery ectasia
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter, ECGDiagnostic test
Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Ectasia patients | Not described Receives: Diagnostic Test: Holter, ECG | |
| Normal coronary artery patients | Not described Receives: Diagnostic Test: Holter, ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precence of arrhythmias in 24 hours Holter monitoring
Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
Measured: 1 year
Secondary outcomes (2)
• Heart rate variability in Holter monitoring
Heart rate variability in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
Measured: 1 year
• Silent ischemia as detected by Holter
Presence pf ischemia in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery EctasiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Mohsen Nady Kamel, Assiut University
- Investigators
- Tarek Abd El Hameed, Assistant Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106530
- Sponsor's protocol ID
- Arrhythmias in CAE patients
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrhythmogenic Risk Assessment in Coronary Artery Ectasia Patients
- ClinicalTrials.gov ID
- NCT05106530
- Acronym / sponsor ID
- Arrhythmias in CAE patients
- Conditions
- Coronary Artery Ectasia
- Keywords
- Coronary artery ectasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 3 Nov 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.
The investigators thought to explore arrhythmias outcome - hidden arrhythmias, ECG features: Tp-Te interval and Tp-Te/QTc ratio, fQRS among patients with coronary artery ectasia as compared to normal coronary artery patients.
Detailed description
All patients will be subjected to:
- Full history taking:
- Including age, sex, history of DM, HTN, dyslipidemia and Body surface area.
- Holter monitoring for 24 hours:
- Heart rate variability
- Hidden arrhythmias
- Hidden ischemia by monitoring ST segment changes
- Twelve lead ECG:
- fQRS in baseline ECG
- QT dispersion.
- Tp-Te interval and Tp-Te/QTc ratio
- Tp-Te dispersion
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Ectasia patients | – | Diagnostic Test: Holter, ECG |
| Normal coronary artery patients | – | Diagnostic Test: Holter, ECG |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include consecutive eligible patients recruited in Assiut University Heart Hospital
Key inclusion criteria (1 listed)
- Subjects with suspected CAD who are referred for elective coronary angiography and/or interventions
Key exclusion criteria (4 listed)
- Patients with a history of cardiomyopathy and myocardial infarction (MI), left ventricular hypertrophy (LVH), pathological Q wave on ECG, typical left bundle block or right bundle block, incomplete right bundle block, or paced rhythm on ECG.
- Patients with severe renal impairment
- Post CABG patients
- Patients of acute coronary syndrome
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 |
|---|---|---|
| Holter, ECGIncidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients. | Diagnostic test | Coronary Artery Ectasia patients, Normal coronary artery patients |
Primary outcome
Precence of arrhythmias in 24 hours Holter monitoring
Time frame: 1 year
Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
2 secondary outcomes
• Heart rate variability in Holter monitoring
Time frame: 1 year
• Silent ischemia as detected by Holter
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- 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.
Tarek Abd El Hameed, Assistant Professor principal investigator
Assiut 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 Coronary Artery Ectasia, run by Assiut 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?
The sponsor lists 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark M N Kamel, Resident (+201274327737, markkamel1994@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precence of arrhythmias in 24 hours Holter monitoring (time frame: 1 year). 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 3 Nov 2021.