Clinical trial NCT04104048: Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
Official title: Short Term Outcome Of Primary Precutaneous Coronary Intervention In Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients presenting with Previous PCI to LAD.
2. Patients presenting with Previous CABG.
3. Patients presenting with NSTEMI ACS.

Primary outcomes:
measure: Short term Outcome of Primary Percutaneous Coronary Intervention in Ostial Versus Non-Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infarction
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: study principal investigator Assiut university
name: youstina marzook, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.