Acute Myocardial InfarctionNCT04104048
Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
An observational study of Acute Myocardial Infarction, run by Assiut University.
Trial summary
To compare short-term clinical outcomes of primary PCI between the ostial LAD-AMI and the non-ostial LAD-AMI. The primary endpoint was the major cardiovascular events (MACE) defined as being the composite of cardiac death, AMI, stent thrombosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology. 2. Onset of maximal intensity of chest pain within 12 hours before procedure
Who may be able to join
- Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology.
- Onset of maximal intensity of chest pain within 12 hours before procedure
Who cannot join
- Patients presenting with Previous PCI to LAD.
- Patients presenting with Previous CABG.
- Patients presenting with NSTEMI ACS.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short Term Outcome Of Primary Precutaneous Coronary Intervention In Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
To compare short-term clinical outcomes of primary PCI between the ostial LAD-AMI and the non-ostial LAD-AMI. The primary endpoint was the major cardiovascular events (MACE) defined as being the composite of cardiac death, AMI, stent thrombosis
Read the detailed description
Current guidelines recommend percutaneous coronary intervention (PCI) for most patients with ST segment elevation acute myocardial infarction (STEMI) or with non ST segment elevation acute coronary syndrome (NSTEACS) (1), (2). In STEMI patients, PCI is advised in all patients in the first 12 hours after onset of symptoms, the earlier the better (1).
Coronary revascularization does not always lead to coronary reperfusion. The development of devices and procedure has improved clinical outcomes of percutaneous coronary intervention (PCI) to the culprit of acute myocardial infarction (AMI) (3-5).
However, proximal left anterior descending artery (LAD)-AMI has still been associated with high morbidity and mortality because of the broad ischemic area (6, 7). In fact, clinical outcomes were significantly worse in the proximal LAD-AMI as compared with the mid LAD-AMI.5) Moreover, the proximal LAD disease in stable angina was closely associated with early revascularization following optimal medical therapy (8). Therefore, clinical guidelines regarding coronary revascularization have discriminated the proximal LAD disease from other LAD diseases (9).
In terms of coronary revascularization, the ostial LAD disease requires special attention in the proximal LAD disease, because percutaneous coronary interventions (PCI) can be more complex in the ostial LAD disease than in the non-ostial proximal LAD disease (10) even in the setting of AMI, left-main-trunk (LMT)-to-LAD crossover stenting was frequently required in the ostial LAD disease (11).
- Conditions
- Acute Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients who were diagnosed as Anterior STEMI | 1. Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology. 2. Onset of maximal intensity of chest pain within 12 hours before procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term Outcome of Primary Percutaneous Coronary Intervention in Ostial Versus Non-Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infarction
To compare short-term clinical outcomes of primary PCI between the ostial LAD-AMI and the non-ostial LAD-AMI. The primary endpoint was the major cardiovascular events (MACE) defined as being the composite of cardiac death, AMI, stent thrombosis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startSep 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, youstina marzook, Assiut University
- Investigators
- youstina marzook, Msc, Principal investigator, study principal investigator Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104048
- Sponsor's protocol ID
- acute myocardial infraction
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yamamoto K, Sakakura K, Akashi N, Watanabe Y, Noguchi M, Taniguchi Y, Wada H, Momomura SI, Fujita H. Comparison of Clinical Outcomes between the Ostial Versus Non-Ostial Culprit in Proximal Left Anterior Descending Artery Acute Myocardial Infarction. Int Heart J. 2019 Jan 25;60(1):37-44. doi: 10.1536/ihj.18-067. Epub 2018 Nov 20.
PubMed 30464130
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome Of Primary Precutaneous Coronary Intervention In Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
- ClinicalTrials.gov ID
- NCT04104048
- Acronym / sponsor ID
- acute myocardial infraction
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 26 Sep 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.
To compare short-term clinical outcomes of primary PCI between the ostial LAD-AMI and the non-ostial LAD-AMI. The primary endpoint was the major cardiovascular events (MACE) defined as being the composite of cardiac death, AMI, stent thrombosis
Detailed description
Current guidelines recommend percutaneous coronary intervention (PCI) for most patients with ST segment elevation acute myocardial infarction (STEMI) or with non ST segment elevation acute coronary syndrome (NSTEACS) (1), (2). In STEMI patients, PCI is advised in all patients in the first 12 hours after onset of symptoms, the earlier the better (1).
Coronary revascularization does not always lead to coronary reperfusion. The development of devices and procedure has improved clinical outcomes of percutaneous coronary intervention (PCI) to the culprit of acute myocardial infarction (AMI) (3-5).
However, proximal left anterior descending artery (LAD)-AMI has still been associated with high morbidity and mortality because of the broad ischemic area (6, 7). In fact, clinical outcomes were significantly worse in the proximal LAD-AMI as compared with the mid LAD-AMI.5) Moreover, the proximal LAD disease in stable angina was closely associated with early revascularization following optimal medical therapy (8). Therefore, clinical guidelines regarding coronary revascularization have discriminated the proximal LAD disease from other LAD diseases (9).
In terms of coronary revascularization, the ostial LAD disease requires special attention in the proximal LAD disease, because percutaneous coronary interventions (PCI) can be more complex in the ostial LAD disease than in the non-ostial proximal LAD disease (10) even in the setting of AMI, left-main-trunk (LMT)-to-LAD crossover stenting was frequently required in the ostial LAD disease (11).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who were diagnosed as Anterior STEMI | – | –1. Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology. 2. Onset of maximal intensity of chest pain within 12 hours before procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology. 2. Onset of maximal intensity of chest pain within 12 hours before procedure
Key inclusion criteria (2 listed)
- Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology.
- Onset of maximal intensity of chest pain within 12 hours before procedure
Key exclusion criteria (3 listed)
- Patients presenting with Previous PCI to LAD.
- Patients presenting with Previous CABG.
- Patients presenting with NSTEMI ACS.
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
Short term Outcome of Primary Percutaneous Coronary Intervention in Ostial Versus Non-Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infarction
Time frame: baseline
To compare short-term clinical outcomes of primary PCI between the ostial LAD-AMI and the non-ostial LAD-AMI. The primary endpoint was the major cardiovascular events (MACE) defined as being the composite of cardiac death, AMI, stent thrombosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Background: PubMed 30464130Yamamoto K, Sakakura K, Akashi N, Watanabe Y, Noguchi M, Taniguchi Y, Wada H, Momomura SI, Fujita H. Comparison of Clinical Outcomes between the Ostial Versus Non-Ostial Culprit in Proximal Left Anterior Descending Artery Acute Myocardial Infarction. Int Heart J. 2019 Jan 25;60(1):37-44. doi: 10.1536/ihj.18-067. Epub 2018 Nov 20.
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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.
youstina marzook, Msc principal investigator
study principal investigator Assiut university
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, 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 3 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 20 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 yehia taha, professor (01223971269, ytkishk2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term Outcome of Primary Percutaneous Coronary Intervention in Ostial Versus Non-Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infarction (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104048, which also lists 1 linked publication.
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 20 May 2020.