Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myocardial Infarction

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: yehia taha, professor; Phone Number: 01223971269; Email: ytkishk2002@yahoo.com
• Study Contact Backup: Name: khaled mohammed, lecturer; Phone Number: 01002580844; Email: Kh_elmaghraby@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients who were diagnosed as Anterior STEMI; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: youstina marzook, Msc, study principal investigator Assiut university

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: acute myocardial infraction

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No