Clinical trial NCT06013813: 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
Overall status: RECRUITING
Phase: NA
Conditions: STEMI - ST Elevation Myocardial Infarction
Myocardial Infarction
Acute Coronary Syndrome
Keywords: STEMI
distal radial access
conventional radial access
MACE
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 2922
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 24 hours and 30 days after PCI.
Secondary outcomes:
measure: Incidence of myocardial infarction after the procedure
timeFrame: 24 hours to 30 days after PCI
measure: Incidence of cerebral vascular event (hemorrhagic or ischemic stroke) after the procedure
timeFrame: 24 hours to 30 days after PCI.
measure: Urgent TVR (Revascularization of the treated vessel)
timeFrame: If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.
measure: Definite stent thrombosis
timeFrame: If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.
measure: 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.
timeFrame: 24 hours to 30 days after PCI.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiología Ignacio Chávez
Study officials:
affiliation: Guering Eid-Lidt
name: Guering Eid Lidt, PhD
role: STUDY_CHAIR
References:
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