Myocardial InfarctionNCT05097755
The Time Delay Correlated With LV Functions and Heart Failure Incidence in STEMI?!
An observational study of Myocardial Infarction, run by mustafa Zayan Abdelsayed Mohamed.
Trial summary
To find out if the time delays between the first medical contacts till the device has an impact on LV functions estimated by transthoracic Echocardiography and if it's correlated to heart failure incidence in non-diabetic patients with STEMI treated with primary PCI Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Myocardial Infarction
- How many people
- 345 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Oct 2024
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: * All patients will be subjected to: * Calculation of time from the first medical contact to time of primary PCI. * Full history taking: including age, sex, history of HTN, Smoking, dyslipidemia, IHD
Who may be able to join
- Subjects with anterior STEMI according to ESC guidelines 2017.
- Subjects undergoing PPCI for the first time .
- Non diabetic patients.
Who cannot join
- • Patients with previous PCI.
- Patients with previous CABG.
- Patients with TIMI flow II or less .
- Cardiogenic shock.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: In Non-diabetic Patients With STEMI Treated With Primary PCI: is the Time Delay Correlated With LV Functions and Heart Failure Incidence?!
To find out if the time delays between the first medical contacts till the device has an impact on LV functions estimated by transthoracic Echocardiography and if it's correlated to heart failure incidence in non-diabetic patients with STEMI treated with primary PCI
- Conditions
- Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
to what extent could the time be relevant to the incidence of Heart failure
is the time delay correlated with LV functions and heart failure incidence?!
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Mar 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- mustafa Zayan Abdelsayed Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mustafa Zayan Abdelsayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097755
- Sponsor's protocol ID
- LV functions in STEMI
- Status last verified
- Jan 2023
- First submitted
- 17 Oct 2021
- Last updated
- 25 Jan 2023
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Non-diabetic Patients With STEMI Treated With Primary PCI: is the Time Delay Correlated With LV Functions and Heart Failure Incidence?!
- ClinicalTrials.gov ID
- NCT05097755
- Acronym / sponsor ID
- LV functions in STEMI
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- mustafa Zayan Abdelsayed MohamedUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 28 Oct 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.
To find out if the time delays between the first medical contacts till the device has an impact on LV functions estimated by transthoracic Echocardiography and if it's correlated to heart failure incidence in non-diabetic patients with STEMI treated with primary PCI
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * All patients will be subjected to: * Calculation of time from the first medical contact to time of primary PCI. * Full history taking: including age, sex, history of HTN, Smoking, dyslipidemia, IHD
Key inclusion criteria (3 listed)
- Subjects with anterior STEMI according to ESC guidelines 2017.
- Subjects undergoing PPCI for the first time .
- Non diabetic patients.
Key exclusion criteria (4 listed)
- • Patients with previous PCI.
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
to what extent could the time be relevant to the incidence of Heart failure
Time frame: baseline
is the time delay correlated with LV functions and heart failure incidence?!
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by mustafa Zayan Abdelsayed Mohamed.
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 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 25 Jan 2023. 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?
Contact Mustafa Z. Abdelsayed (+20 1067982167, mustafa.zaian54@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to what extent could the time be relevant to the incidence of Heart failure (time frame: baseline). 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 25 Jan 2023.