Culprit-first in Primary Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

Official title:

Culprit-first Versus Culprit-last Approach During Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05415085
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: April 13, 2023

Study information

• Verified date: October 2023
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the impact of culprit-first versus culprit-last percutaneous coronary intervention on the door to balloon time and clinical outcomes in patients with ST-elevation myocardial infarction.

Description:

Ischemic heart disease (IHD) is the single most common cause of death and its frequency is increasing globally. It is estimated that IHD is the cause of 1.8 million deaths or 20% of all deaths in Europe. Despite advancements in the fields of rapid diagnosis and in treatment strategies, the morbidity, and mortality in patients with ST-segment myocardial infarction remains substantial, with an estimated mortality rate of 4-12% according to registries of the ESC countries. According to the 2017 European Society of Cardiology (ESC) guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation (STEMI), there is a level 1 recommendation with a level of evidence A for primary percutaneous coronary intervention (PPCI) strategy in patients with STEMI, and this strategy is preferred over fibrinolytic therapy. In addition, the ESC guidelines recommend a first medical contact to reperfusion time within 60 minutes in STEMI patients for primary PCI-capable centers. This recommendation is supported by a recently published study that showed shortening door to balloon (D2B) time was significantly associated with survival benefit. Based on the recommendation for maximal D2B time in STEMI patients to be 60 minutes, many countries and institutions worldwide have established programs, among them the national program for quality indicators by the Israeli ministry of health, to shorten D2B times. According to data published by the Israeli ministry of health in the year 2018, 88% of STEMI patients had a D2B time of <90 minutes. The common practice during PPCI is to complete diagnostic angiography of the whole coronary tree before performing culprit-vessel revascularization. This practice is not evidence-based and current guidelines do not prioritize full diagnostic angiography over culprit-vessel revascularization first. As was found in previous studies, this practice might result in delaying revascularization by 4-8 minutes in D2B time. This delay might potentially lead to worse outcomes in STEMI patients, although not proven in the above-cited studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 13, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Patients presenting with STEMI who are eligible for PPCI

Exclusion Criteria:

• Cardiac arrest
• Cardiopulmonary resuscitation or extracorporeal membrane oxygenation on arrival to the catheterization laboratory
• Prior coronary artery bypass grafting surgery

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• STEMI
• Stent

Intervention

Procedure:
• Culprit-first PCI
PCI to the culprit artery prior to the demonstration of the whole coronary tree.

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Needle-to-balloon time of 10 minutes or less	Change in needle-to-balloon time in minutes	through study completion, an average of 1 year
Secondary	Need for hemodynamic (mechanical/medical) support during PCI	Number of patients that needed mechanical support during PCI	through study completion, an average of 1 year
Secondary	Need for respiratory support during PCI	Number of patients that needed respiratory support during PCI	through study completion, an average of 1 year
Secondary	Rate of failed PCI	As determined by the operator	through study completion, an average of 1 year