Clinical trial NCT05415085: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Myocardial Infarction
STEMI
Stent
Keywords: coronary artery disease
STEMI
primary PCI
door-to-balloon time
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Needle-to-balloon time of 10 minutes or less
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Need for hemodynamic (mechanical/medical) support during PCI
timeFrame: through study completion, an average of 1 year
measure: Need for respiratory support during PCI
timeFrame: through study completion, an average of 1 year
measure: Rate of failed PCI
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Nir Levi, MD
role: PRINCIPAL_INVESTIGATOR
References: