Subarachnoid HemorrhageNCT04177329
Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, run by Assiut University.
Trial summary
Patients with subarachnoid haemorrhage frequently develop cardiac complications affecting their outcome Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presented with spontaneous subarachnoid hemorrhage admitted to our department included in this study
Who may be able to join
- Patients diagnosed as spontaneous subarachnoid hemorrhage.
- SSAH patients aged (18-70 years) of both sexes
Who cannot join
- History or current evidence of any CNS disease other than SAH which may cause cardiac complications.
- History or current evidence of medical illness as endocrinal and metabolic disorders which may cause cardiac complications
About this study
Patients with subarachnoid haemorrhage frequently develop cardiac complications affecting their outcome
- Conditions
- Subarachnoid Hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrocadriogram
to measure heart rate (beats/minute) in subarachnoid hemorrhage patients
Measured: 1 miute
Echocardiogarphy
to measure ejection fraction (%) in subarachnoid hemorrhage patients
Measured: 30 minute
Secondary outcomes (1)
serum treponin level
to measure serum treponin(ng/ml)in subarachnoid hemorrhage patients
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reda Omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177329
- Sponsor's protocol ID
- Impact of cardiac complication
- Status last verified
- Nov 2019
- First submitted
- 23 Sep 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT04177329
- Acronym / sponsor ID
- Impact of cardiac complication
- Conditions
- Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Nov 2019 (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.
Patients with subarachnoid haemorrhage frequently develop cardiac complications affecting their outcome
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presented with spontaneous subarachnoid hemorrhage admitted to our department included in this study
Key inclusion criteria (2 listed)
- Patients diagnosed as spontaneous subarachnoid hemorrhage.
- SSAH patients aged (18-70 years) of both sexes
Key exclusion criteria (2 listed)
- History or current evidence of any CNS disease other than SAH which may cause cardiac complications.
- History or current evidence of medical illness as endocrinal and metabolic disorders which may cause cardiac complications
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
Electrocadriogram
Time frame: 1 miute
to measure heart rate (beats/minute) in subarachnoid hemorrhage patients
Echocardiogarphy
Time frame: 30 minute
to measure ejection fraction (%) in subarachnoid hemorrhage patients
1 secondary outcome
serum treponin level
Time frame: 30 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by Assiut University.
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 2 inclusion and 2 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Electrocadriogram (time frame: 1 miute). 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 26 Nov 2019.