Culprit-first in Primary Percutaneous Coronary Intervention
Primary Purpose
Coronary Artery Disease, Ischemic Heart Disease, Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Culprit-first PCI
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, STEMI, primary PCI, door-to-balloon time
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
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Culprit-first PCI
Culprit-last PCI
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Needle-to-balloon time of 10 minutes or less
Change in needle-to-balloon time in minutes
Secondary Outcome Measures
Need for hemodynamic (mechanical/medical) support during PCI
Number of patients that needed mechanical support during PCI
Need for respiratory support during PCI
Number of patients that needed respiratory support during PCI
Rate of failed PCI
As determined by the operator
Full Information
NCT ID
NCT05415085
First Posted
April 27, 2022
Last Updated
October 17, 2023
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05415085
Brief Title
Culprit-first in Primary Percutaneous Coronary Intervention
Official Title
Culprit-first Versus Culprit-last Approach During Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
April 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ischemic Heart Disease, Myocardial Infarction, STEMI, Stent
Keywords
coronary artery disease, STEMI, primary PCI, door-to-balloon time
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Culprit-first PCI
Arm Type
Experimental
Arm Description
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.
Arm Title
Culprit-last PCI
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Culprit-first PCI
Intervention Description
PCI to the culprit artery prior to the demonstration of the whole coronary tree.
Primary Outcome Measure Information:
Title
Needle-to-balloon time of 10 minutes or less
Description
Change in needle-to-balloon time in minutes
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Need for hemodynamic (mechanical/medical) support during PCI
Description
Number of patients that needed mechanical support during PCI
Time Frame
through study completion, an average of 1 year
Title
Need for respiratory support during PCI
Description
Number of patients that needed respiratory support during PCI
Time Frame
through study completion, an average of 1 year
Title
Rate of failed PCI
Description
As determined by the operator
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Levi, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Culprit-first in Primary Percutaneous Coronary Intervention
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