Culprit-first in Primary Percutaneous Coronary Intervention

October 17, 2023 updated by: Nir Levi, Shaare Zedek Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Culprit-first PCI
PCI to the culprit artery prior to the demonstration of the whole coronary tree.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needle-to-balloon time of 10 minutes or less
Time Frame: through study completion, an average of 1 year
Change in needle-to-balloon time in minutes
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for hemodynamic (mechanical/medical) support during PCI
Time Frame: through study completion, an average of 1 year
Number of patients that needed mechanical support during PCI
through study completion, an average of 1 year
Need for respiratory support during PCI
Time Frame: through study completion, an average of 1 year
Number of patients that needed respiratory support during PCI
through study completion, an average of 1 year
Rate of failed PCI
Time Frame: through study completion, an average of 1 year
As determined by the operator
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Nir Levi, MD, Shaare Zedek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

April 13, 2023

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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