Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI

Not Applicable

Recruiting

• Conditions: Myocardial Infarction; STEMI - ST Elevation Myocardial Infarction; Acute Coronary Syndrome
• Interventions: Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)

• Registration Number: NCT06013813
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary

This clinical trial aims to compare conventional radial access versus distal radial access in patients with STEMI undergoing PCI. The main question it aims to answer is:

• Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not inferior when comparing the distal radial approach versus the conventional radial approach ?

Participants will:

* sign the informed consent to enroll in the clinical trial.

* will agree to be treated by PCI

* will be randomized 1:1 to perform PCI by conventional radial or distal radial approach.

If there is a comparison group:

Researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal MACE and a similar rate of a successful procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-28
• Study Start: 2023-09-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-12
• Last Update Posted: 2023-11-15
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2922

Inclusion Criteria

• STEMI patients underwent PCI.
• Patent radial access (distal and conventional)
• Patients who agree to participate in the study and sign the informed consent form.

Exclusion Criteria

• Cardiogenic shock.
• Previous coronary artery bypass grafting (CABG).
• Absence of palpable radial pulse.
• Arteriovenous fistula for hemodialysis.
• Previous radial artery occlusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional radial approach (proximal radial approach).	Radial Artery approach on percutaneous coronary intervention (PCI)	* Clean and dry the puncture site. * Simple lidocaine 2% is infiltrated. * The artery is punctured in the radial proximal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique. * Verapamil 2.5 mg and Heparin 5000 IU are administered. * PCI is performed. * Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (terumo).
Distal radial approach	Radial Artery approach on percutaneous coronary intervention (PCI)	* Clean and dry the puncture site. * Simple lidocaine 2% is infiltrated. * The artery is punctured in the radial distal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique. * Verapamil 2.5 mg and Heparin 5000 IU are administered. * PCI is performed. * Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (prelude mostly or terumo).

Primary Outcome Measures

Name	Time	Method
Composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3-5 (Bleeding Academic Research Consortium), myocardial infarction and cerebrovascular event, bleeding measure will be with BARC classification.	24 hours and 30 days after PCI.	At 24 hours and 30 days after the procedure, patients will be evaluated by radial doppler ultrasonography, lab test, and interrogation of clinical adverse events during hospital stay or 30 days after PCI.

Secondary Outcome Measures

Name	Time	Method
Incidence of cerebral vascular event (hemorrhagic or ischemic stroke) after the procedure	24 hours to 30 days after PCI.	Diagnosed by a doctor based on clinical symptoms and imaging tests (CT scan).
Incidence of myocardial infarction after the procedure	24 hours to 30 days after PCI	A new STEMI event is an event that meets the fourth definition of a myocardial infarction according to the current guidelines.
Bleeding assessed by BARC 3-5 to 30 days of evolution in patients with STEMI who received interventional treatment via RD access versus RC access.	24 hours to 30 days after PCI.	Evaluated by BARC scale will be used to classify the severity of bleeding into types 0-5 (3-5 are the most important criteria for the clinical trial will define the worse outcome ) Type 0 = no evidence of bleeding Type 1 = minimal bleeding Type 2 = clinically evident bleeding other than 3, 4 or 5 Type 3 = with haematocrit fall ≥ 3g% and/or hemodynamic compromise and/or requiring transfusion and/or intracranial or intraocular bleeding Type 4 = associated with Myocardial Revascularization Surgery Type 5 = fatal bleeding.
Definite stent thrombosis	If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.	Diagnosed by coronary angiography or intracoronary imaging (IVUS/OCT) showing a complication related to the culprit vessel of the initial event.
Urgent TVR (Revascularization of the treated vessel)	If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.	Diagnosed by coronary angiography or intracoronary imaging (IVUS/OCT) showing a complication related to the culprit vessel of the initial event.

Trial Locations

Locations (1)

Instituto Nacional de Cardiología Ignacio Chávez; 🇲🇽 Mexico City, Mexico