Culprit-first in Primary Percutaneous Coronary Intervention

NCT ID: NCT05415085

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-04-13

Brief 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.

Detailed 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.

Conditions

Coronary Artery Disease; Ischemic Heart Disease; Myocardial Infarction; STEMI; Stent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Culprit-first PCI

In this arm, primary PCI with stent implantation will be performed prior to the demonstration of the whole coronary tree. The suspected culprit artery will be demonstrated first and the PCI will be performed.

Group Type: EXPERIMENTAL

Culprit-first PCI

Intervention Type: PROCEDURE

PCI to the culprit artery prior to the demonstration of the whole coronary tree.

Culprit-last PCI

In this arm, primary PCI with stent implantation will be performed after the demonstration of the whole coronary tree. The suspected culprit artery will be demonstrated after the contralateral side and then PCI will be performed. This is the common approach.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Culprit-first PCI

PCI to the culprit artery prior to the demonstration of the whole coronary tree.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nir Levi

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nir Levi, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

Shaare Zedek Medical Center

Jerusalem, , Israel

Countries

Israel

References

Levi N, Wolff R, Jubeh R, Shuvy M, Steinmetz Y, Perel N, Maller T, Amsalem I, Hitter R, Asher E, Turyan A, Karmi M, Orlev A, Dratva D, Khoury Z, Hasin T, Wolak A, Glikson M, Dvir D. Culprit Lesion Coronary Intervention Before Complete Angiography in ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e243729. doi: 10.1001/jamanetworkopen.2024.3729.

Reference Type: DERIVED

PMID: 38551563 (View on PubMed)

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id