Acute Coronary Syndrome, Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
Conditions
Keywords
STEMI, distal radial access, conventional radial access, MACE
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.
Interventions
PROCEDURERadial 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.
Sponsors
Instituto Nacional de Cardiologia Ignacio Chavez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
Mexico
Contacts
Primary ContactJuan Carlos Plata Corona, PhD
Backup ContactGuering Eid Lidt, PhD
Outcome results
None listed