Culprit-first in Primary Percutaneous Coronary Intervention

NCT05415085 | Completed DMC

• 1 other identifier: 002
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

coronary artery disease; STEMI; primary PCI; door-to-balloon time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Need for hemodynamic (mechanical/medical) support during PCI

  through study completion, an average of 1 year

• Need for respiratory support during PCI

  through study completion, an average of 1 year

• Rate of failed PCI

  through study completion, an average of 1 year

Study Arms (2)

Culprit-first PCI

EXPERIMENTAL

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

Culprit-last PCI

NO INTERVENTION

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.

Interventions

Culprit-first PCI PROCEDURE

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

Culprit-first PCI

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with STEMI who are eligible for PPCI

You may not qualify if:

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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Related Publications (1)

• 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.

  PMID: 38551563 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nir Levi, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: June 10, 2022
• Study Start: May 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: April 13, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)