Transient Ischemic AttackNCT04679987
Incidence of Paroxysmal Atrial Fibrillation (AF) in Patients With Acute Ischemic Stroke or Transient Ischemic Attacks (TIAs) by 48 Hours Holter Monitoring
An observational study of Transient Ischemic Attack, run by Helwan University at 1 site in Egypt.
Trial summary
200 patients presenting with symptoms of acute ischemic stroke or transient ischemic attack were included. All patients free of AF on presentation underwent 48 hours Holter monitoring within one week. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Transient Ischemic Attack
- What is being tested?
- Holter ECG
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed as acute stroke or TIA in stroke unit and neurology outpatient clinic, neurology Department, faculty of medicine, Misr University for Science and Technology (MUST) University
Who may be able to join
- patient with acute ischemic stroke or TIAs (within one week of onset)
Who cannot join
- history of persistent AF
- initial ECG is AF
- primary hemorrhagic stroke
- acute large vessel dissection
- inability or refusal of consent
Trial locations and contacts
1 site in 1 country.
About this study
200 patients presenting with symptoms of acute ischemic stroke or transient ischemic attack were included. All patients free of AF on presentation underwent 48 hours Holter monitoring within one week.
- Conditions
- Transient Ischemic Attack
- Being tested
- Holter ECG
- Keywords
- atrial fibrillation, transient ischemic attack
- Medical subject headings
- Ischemic Attack, Transient, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter ECGDiagnostic test
all patients will be monitored for paroxysmal Af by holder ECG
| Study group | Role | What they receive |
|---|---|---|
| paroxysmal Af | Not described Receives: Diagnostic Test: Holter ECG | |
| no paroxysmal Af | Not described Receives: Diagnostic Test: Holter ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of paroxysmal Af
incidence of paroxysmal Af after TIA
Measured: March 2019 -November 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Mar 2019
- Primary completion1 Oct 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AttackStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Badr Salem, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679987
- Sponsor's protocol ID
- AFTIA
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Paroxysmal Atrial Fibrillation (AF) in Patients With Acute Ischemic Stroke or Transient Ischemic Attacks (TIAs) by 48 Hours Holter Monitoring
- ClinicalTrials.gov ID
- NCT04679987
- Acronym / sponsor ID
- AFTIA
- Conditions
- Transient Ischemic Attack
- Keywords
- atrial fibrillation, transient ischemic attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Dec 2020 (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.
200 patients presenting with symptoms of acute ischemic stroke or transient ischemic attack were included. All patients free of AF on presentation underwent 48 hours Holter monitoring within one week.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paroxysmal Af | – | Diagnostic Test: Holter ECG |
| no paroxysmal Af | – | Diagnostic Test: Holter ECG |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed as acute stroke or TIA in stroke unit and neurology outpatient clinic, neurology Department, faculty of medicine, Misr University for Science and Technology (MUST) University
Key inclusion criteria (1 listed)
- patient with acute ischemic stroke or TIAs (within one week of onset)
Key exclusion criteria (5 listed)
- history of persistent AF
- initial ECG is AF
- primary hemorrhagic stroke
- acute large vessel dissection
- inability or refusal of consent
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 ECGall patients will be monitored for paroxysmal Af by holder ECG | Diagnostic test | no paroxysmal Af, paroxysmal Af |
Primary outcome
presence of paroxysmal Af
Time frame: March 2019 -November 2020
incidence of paroxysmal Af after TIA
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 28 Dec 2020.
- 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 Transient Ischemic Attack, run by Helwan 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 5 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 28 Dec 2020. 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?
presence of paroxysmal Af (time frame: March 2019 -November 2020). 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 28 Dec 2020.