ST Elevation Myocardial InfarctionNCT03310437
Cost Effectiveness if Primary PCI Versus Thrombolytic Therapy in Acute STEMI in Assiut University Hospital
An observational study of ST Elevation Myocardial Infarction, run by Nahed Sameh Zaki at 1 site in Egypt.
Trial summary
Cost effectiveness between PPCI and thrombolytic therapy in STEMI patients without contraindications Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Primary PCI
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2018to 1 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients presented by ST elevation myocardial infarction
Who may be able to join
- All PPCI patients within 90 minutes door to ballon.
- All thrombolytic patient without contraindication ,within 6 golden hours of chest pain.
Who cannot join
- patients don't meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost Effectiveness of Primary PCI Versus Thrombolytic Therapy in STEMI in Assiut University Hospital
Cost effectiveness between PPCI and thrombolytic therapy in STEMI patients without contraindications
Read the detailed description
Cost effectiveness between PPCI and thrombolytic therapy in STEMI patients 100 patient each within 90 m for PPCI and 6h for thrombolytic
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Primary PCI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary PCIProcedure or surgery
Primary percutaneous coronary intervention in acute myocardial infarction patients
| Study group | Role | What they receive |
|---|---|---|
| Primary PCI | In primary PCI we use arterial sheath , wires ,heparin ,intracoronary stents Receives: Procedure: Primary PCI | |
| Thrombolytic | In patients recieving thrombolytics they continue on LWMH for 72h ,plus aspirin , clopedogril , BB, statins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare between PPCI and thrombolytic therapy regarding over all cost in STEMI patients
we will compare different outcomes in ST elevation myocardial infarction patients presented to our hospital who had recieved intervention (primary PCI ) versus thrombolytic as regarded in all over cost in egyptian pounds and follow up for 6 month
Measured: one year for collecting 100 patient for each arm with follow up 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start7 Feb 2018
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahed Sameh Zaki
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Nahed Sameh Zaki, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310437
- Sponsor's protocol ID
- 81
- Status last verified
- Jul 2019
- First submitted
- 25 Sep 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness of Primary PCI Versus Thrombolytic Therapy in STEMI in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03310437
- Acronym / sponsor ID
- 81
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nahed Sameh ZakiUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 16 Oct 2017 (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.
Cost effectiveness between PPCI and thrombolytic therapy in STEMI patients without contraindications
Detailed description
Cost effectiveness between PPCI and thrombolytic therapy in STEMI patients 100 patient each within 90 m for PPCI and 6h for thrombolytic
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary PCI | – | Procedure: Primary PCIIn primary PCI we use arterial sheath , wires ,heparin ,intracoronary stents |
| Thrombolytic | – | –In patients recieving thrombolytics they continue on LWMH for 72h ,plus aspirin , clopedogril , BB, statins |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presented by ST elevation myocardial infarction
Key inclusion criteria (2 listed)
- All PPCI patients within 90 minutes door to ballon.
- All thrombolytic patient without contraindication ,within 6 golden hours of chest pain.
Key exclusion criteria (1 listed)
- patients don't meet inclusion criteria
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 |
|---|---|---|
| Primary PCIPrimary percutaneous coronary intervention in acute myocardial infarction patients | Procedure or surgery | Primary PCI |
Primary outcome
Compare between PPCI and thrombolytic therapy regarding over all cost in STEMI patients
Time frame: one year for collecting 100 patient for each arm with follow up 6 month
we will compare different outcomes in ST elevation myocardial infarction patients presented to our hospital who had recieved intervention (primary PCI ) versus thrombolytic as regarded in all over cost in egyptian pounds and follow up for 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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.
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 ST Elevation Myocardial Infarction, run by Nahed Sameh Zaki 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 2 inclusion and 1 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 5 Jul 2019. 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 Nahed Sameh (01224721313, nahedsameh74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare between PPCI and thrombolytic therapy regarding over all cost in STEMI patients (time frame: one year for collecting 100 patient for each arm with follow up 6 month). 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 5 Jul 2019.