No-Reflow PhenomenonNCT04785209
Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing Primary Percutaneous Coronary Intervention.
An observational study of No-Reflow Phenomenon, run by Assiut University at 1 site in Egypt.
Trial summary
Predicting no reflow in ppci of STEMI patients using mean platelet volume together with STEMI clinical risk scores Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- No-Reflow Phenomenon
- What is being tested?
- Mean platelet volume, lymphocyte number, STEMI clinical risk scores
- How many people
- 640 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 May 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: All STEMI patients presenting within 24 hrs of onset of symptoms
Who may be able to join
- patients presenting with acute STEMI, within 24 hours of symptoms, fulfilling criteria for PPCI protocol in our facility
Who cannot join
- patients presenting more than 24 hours of symptoms onset
- patients not eligible for PPCI program in our facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing PPCI.
Predicting no reflow in ppci of STEMI patients using mean platelet volume together with STEMI clinical risk scores
- Conditions
- No-Reflow Phenomenon
- Being tested
- Mean platelet volume, lymphocyte number, STEMI clinical risk scores
- Medical subject headings
- No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mean platelet volume, lymphocyte number, STEMI clinical risk scoresOther
Lab parameters
| Study group | Role | What they receive |
|---|---|---|
| No complication | Thrombolysis in myocardial infarction flow grade III flow after PPCI, mean platelet volume, lymphocyte ratio, detailed echo within 24 hrs of admission, clinical STEMI risk scores Receives: Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scores | |
| No reflow | No reflow phenomenon after pci on STEMI patients, mean platelet volume, lymphocyte ratio, detailed echo within 24 hrs of admission, clinical STEMI risk scores Receives: Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participents with No reflow after PPCI and in hospital mortality
No reflow: suboptimal myocardial reperfusion through a part of coronary circulation without angiographic evidence of mechanical vessel obstruction.
In hospital mortality
Measured: Within 48 hours from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Sep 2020
- Primary completion28 Feb 2021
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No-Reflow PhenomenonStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Reymon Sadik Salama, Assiut University
- Investigators
- Hamdy Shams elddin, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785209
- Sponsor's protocol ID
- Prediction of No reflow
- Status last verified
- May 2024
- First submitted
- 23 Sep 2020
- Last updated
- 31 May 2024
- 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing PPCI.
- ClinicalTrials.gov ID
- NCT04785209
- Acronym / sponsor ID
- Prediction of No reflow
- Conditions
- No-Reflow Phenomenon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 5 Mar 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.
Predicting no reflow in ppci of STEMI patients using mean platelet volume together with STEMI clinical risk scores
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No complication | – | Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scoresThrombolysis in myocardial infarction flow grade III flow after PPCI, mean platelet volume, lymphocyte ratio, detailed echo within 24 hrs of admission, clinical STEMI risk scores |
| No reflow | – | Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scoresNo reflow phenomenon after pci on STEMI patients, mean platelet volume, lymphocyte ratio, detailed echo within 24 hrs of admission, clinical STEMI risk scores |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All STEMI patients presenting within 24 hrs of onset of symptoms
Key inclusion criteria (1 listed)
- patients presenting with acute STEMI, within 24 hours of symptoms, fulfilling criteria for PPCI protocol in our facility
Key exclusion criteria (2 listed)
- patients presenting more than 24 hours of symptoms onset
- patients not eligible for PPCI program in our facility
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 |
|---|---|---|
| Mean platelet volume, lymphocyte number, STEMI clinical risk scoresLab parameters | Other | No complication, No reflow |
Primary outcome
Number of participents with No reflow after PPCI and in hospital mortality
Time frame: Within 48 hours from admission
No reflow: suboptimal myocardial reperfusion through a part of coronary circulation without angiographic evidence of mechanical vessel obstruction. In hospital mortality
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 31 May 2024.
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Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
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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.
Hamdy Shams elddin, 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 No-Reflow Phenomenon, 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 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: finished, as of the sponsor's last update on 31 May 2024. 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?
Number of participents with No reflow after PPCI and in hospital mortality (time frame: Within 48 hours from admission). 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 31 May 2024.