ST-segment Elevation Myocardial Infarction (STEMI)NCT04110691
Impact of Stent Length and Diameter on Patients Undergoing Primary PCI
An observational study of ST-segment Elevation Myocardial Infarction (STEMI), run by Assiut University.
Trial summary
The goal of the study is to evaluate the Impact of coronary stent length and/or diameter in patients with ST segment myocardial infarction undergoing primary PCI, on Short term clinical outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 28 Jan 2022
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ST segment elevation myocardial infarction undergoing primary PCI
Who may be able to join
- Patients with ST segment myocardial infarction who are eligible for PCI.
- All categories (all age groups and both sex groups)
Who cannot join
- Patients with previous PCI.
- Patients of ectatic lesions.
- Patients with with multi vessel disease and suitable for CABG.
- Patients with complex lesions including bifurcational lesions and LM stenting.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Stent Length and Diameter on Short Term Outcomes in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary PCI.
The goal of the study is to evaluate the Impact of coronary stent length and/or diameter in patients with ST segment myocardial infarction undergoing primary PCI, on Short term clinical outcomes.
Read the detailed description
- ST segment elevation myocardial infarction is serious condition to the blood supply to the heart muscle. Rapid reperfusion of the ischemic myocardium using percutaneous coronary intervention (PCI) is the standard treatment for acute myocardial infarction (MI) to rescue the ischemic myocardium and reduce infarction size.
- There are two types of stents:
- Drug-eluting stent which achieving local drug delivery to the injured blood vessel at the time of intervention, a drug is released from a polymer coating or loaded directly onto the stent (2). This is the best one.
- Bare metal stent is the old one and not effective as DES in reducing vascular restenosis by suppressing smooth muscle cell (SMC) proliferation.
- The management of long coronary lesions by percutaneous coronary intervention (PCI) has become increasingly important because of the rising incidence of long or complex lesions in aging populations (3) Stent length has been considered as an important predictor of adverse events after PCI. The exact impact of lesion length on the short- and long-term clinical outcomes of DES implantations is not clear yet.
- Myocardial necrosis complicates one-third of percutaneous coronary intervention (PCI) and may adversely affect the outcome(4)
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis of patients with ST segment myocardial infarction undergoing primary PCI
prognosis will be measured with ECG and ECHO
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Jul 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion28 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Deyaa, Assiut University
- Investigators
- Nada Deyaa, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110691
- Sponsor's protocol ID
- coronary stents
- Status last verified
- May 2020
- First submitted
- 28 Sep 2019
- Last updated
- 19 May 2020
- 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 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stent Length and Diameter on Short Term Outcomes in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary PCI.
- ClinicalTrials.gov ID
- NCT04110691
- Acronym / sponsor ID
- coronary stents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 28 Jan 2022 (estimated)
- First posted
- 1 Oct 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.
The goal of the study is to evaluate the Impact of coronary stent length and/or diameter in patients with ST segment myocardial infarction undergoing primary PCI, on Short term clinical outcomes.
Detailed description
- ST segment elevation myocardial infarction is serious condition to the blood supply to the heart muscle. Rapid reperfusion of the ischemic myocardium using percutaneous coronary intervention (PCI) is the standard treatment for acute myocardial infarction (MI) to rescue the ischemic myocardium and reduce infarction size.
- There are two types of stents:
- Drug-eluting stent which achieving local drug delivery to the injured blood vessel at the time of intervention, a drug is released from a polymer coating or loaded directly onto the stent (2). This is the best one.
- Bare metal stent is the old one and not effective as DES in reducing vascular restenosis by suppressing smooth muscle cell (SMC) proliferation.
- The management of long coronary lesions by percutaneous coronary intervention (PCI) has become increasingly important because of the rising incidence of long or complex lesions in aging populations (3) Stent length has been considered as an important predictor of adverse events after PCI. The exact impact of lesion length on the short- and long-term clinical outcomes of DES implantations is not clear yet.
- Myocardial necrosis complicates one-third of percutaneous coronary intervention (PCI) and may adversely affect the outcome(4)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ST segment elevation myocardial infarction undergoing primary PCI
Key inclusion criteria (2 listed)
- Patients with ST segment myocardial infarction who are eligible for PCI.
- All categories (all age groups and both sex groups)
Key exclusion criteria (4 listed)
- Patients with previous PCI.
- Patients of ectatic lesions.
- Patients with with multi vessel disease and suitable for CABG.
- Patients with complex lesions including bifurcational lesions and LM stenting.
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
prognosis of patients with ST segment myocardial infarction undergoing primary PCI
Time frame: 3 months
prognosis will be measured with ECG and ECHO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
Nada Deyaa principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of ST-segment Elevation Myocardial Infarction (STEMI), 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 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 19 May 2020. 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 Doaa Ahmed Fouad, Professor (01001085828, fouaddoaa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognosis of patients with ST segment myocardial infarction undergoing primary PCI (time frame: 3 months). 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 19 May 2020.