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

Primary Purpose

STEMI - ST Elevation Myocardial Infarction, Myocardial Infarction, Acute Coronary Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
percutaneous coronary intervention (PCI)
Sponsored by
Instituto Nacional de Cardiologia Ignacio Chavez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction focused on measuring STEMI, distal radial access, conventional radial access, MACE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Nacional de Cardiología Ignacio Chávez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

conventional radial access

distal radial access

Arm Description

STEMI interventional treatment via conventional radial access

STEMI interventional treatment via distal radial access

Outcomes

Primary Outcome Measures

composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3 (Bleeding Academic Research Consortium)
death, myocardial infarction and cerebral vascular event at 30 days (yes / no), bleeding measure will be with BARC classification.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2023
Last Updated
August 22, 2023
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
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1. Study Identification

Unique Protocol Identification Number
NCT06013813
Brief Title
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI - ST Elevation Myocardial Infarction, Myocardial Infarction, Acute Coronary Syndrome
Keywords
STEMI, distal radial access, conventional radial access, MACE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2922 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional radial access
Arm Type
Active Comparator
Arm Description
STEMI interventional treatment via conventional radial access
Arm Title
distal radial access
Arm Type
Active Comparator
Arm Description
STEMI interventional treatment via distal radial access
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention (PCI)
Intervention Description
Conventional vs distal radial access will be selected with computer randomization 1:1
Primary Outcome Measure Information:
Title
composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3 (Bleeding Academic Research Consortium)
Description
death, myocardial infarction and cerebral vascular event at 30 days (yes / no), bleeding measure will be with BARC classification.
Time Frame
30 days after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Plata Corona, PhD
Phone
+522212187940
Email
juancarlosplatacorona3@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guering Eid Lidt, PhD
Phone
+525585803787
Email
gueringeid@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guering Eid Lidt, PhD
Organizational Affiliation
Guering Eid-Lidt
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Nacional de Cardiología Ignacio Chávez
City
Mexico City
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Plata
Phone
+55 2212187940
Email
juancarlosplatacorona3@gmail.com
First Name & Middle Initial & Last Name & Degree
Norman Said Vega Servin, PhD
First Name & Middle Initial & Last Name & Degree
Arnoldo Enmanuel Loaisiga Saenz, PhD
First Name & Middle Initial & Last Name & Degree
Eduardo Agustin Arias Sánchez, PhD
First Name & Middle Initial & Last Name & Degree
Jorge Gaspar Hernandez, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD will be shared
IPD Sharing Time Frame
january 2025 to january 2026
IPD Sharing 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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Results Reference
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Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI

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