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

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ClinicalTrials.gov Identifier: NCT06013813
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : November 15, 2023
Sponsor:
Information provided by (Responsible Party):
Guering Eid Lidt, Instituto Nacional de Cardiologia Ignacio Chavez

Study Description
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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.


Condition or disease Intervention/treatment Phase
STEMI - ST Elevation Myocardial Infarction Myocardial Infarction Acute Coronary Syndrome Procedure: Radial Artery approach on percutaneous coronary intervention (PCI) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2922 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adverse Clinical Outcomes Associated With Conventional Versus Distal Radial Access in Patients With Acute Coronary Syndrome With ST-segment Elevation Treated by Percutaneous Coronary Intervention
Actual Study Start Date : September 7, 2023
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: Distal radial approach
  • 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).
 Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)
  • Randomized patients with a right patent radial artery.
  • The outcomes of the distal radial approach will be compared with those of the conventional radial approach.
  • Technique and devices (introducer and compression devices) are the same in both approaches.
Active Comparator: Conventional radial approach (proximal radial approach).
  • 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).
 Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)
  • Randomized patients with a right patent radial artery.
  • The outcomes of the distal radial approach will be compared with those of the conventional radial approach.
  • Technique and devices (introducer and compression devices) are the same in both approaches.


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. Incidence of myocardial infarction after the procedure [ Time Frame: 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.

  2. Incidence of cerebral vascular event (hemorrhagic or ischemic stroke) after the procedure [ Time Frame: 24 hours to 30 days after PCI. ]
    Diagnosed by a doctor based on clinical symptoms and imaging tests (CT scan).

  3. Urgent TVR (Revascularization of the treated vessel) [ Time Frame: 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.

  4. Definite stent thrombosis [ Time Frame: 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.

  5. 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. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06013813


Contacts
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Contact: Juan Carlos Plata Corona, PhD +522212187940 juancarlosplatacorona3@gmail.com
Contact: Guering Eid Lidt, PhD +525585803787 gueringeid@gmail.com

Locations
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Mexico
Instituto Nacional de Cardiología Ignacio Chávez Recruiting
Mexico City, Mexico
Contact: Carlos Plata    +55 2212187940    juancarlosplatacorona3@gmail.com   
Sub-Investigator: Norman Said Vega Servin, PhD         
Sub-Investigator: Arnoldo Enmanuel Loaisiga Saenz, PhD         
Sub-Investigator: Eduardo Agustin Arias Sánchez, PhD         
Sub-Investigator: Jorge Gaspar Hernandez, PhD         
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
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Study Chair: Guering Eid Lidt, PhD Guering Eid-Lidt
  Study Documents (Full-Text)

Documents provided by Guering Eid Lidt, Instituto Nacional de Cardiologia Ignacio Chavez:
Study Protocol and Statistical Analysis Plan  [PDF] April 22, 2023

More Information
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Publications of Results:

Other Publications:

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Responsible Party: Guering Eid Lidt, Director of Cardiac Catheterization Lab, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT06013813    
Other Study ID Numbers: 23-1367
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: November 15, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: january 2025 to january 2026
Access Criteria: IPD will be shared for related studies, without distinctions in the nature of each study, information may be freely requested directly by e-mail and each request will be evaluated by the principal investigator of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guering Eid Lidt, Instituto Nacional de Cardiologia Ignacio Chavez:
STEMI
distal radial access
conventional radial access
MACE
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Syndrome
Infarction
Disease
Pathologic Processes
 Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases