Safety and Feasibility of Using a Single Transradial Guiding Catheter for Primary PCI

Study Overview
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Brief Summary
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The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI) can reduce procedure time, fluoroscopy time and Cath Lab door to balloon(C2B) time when compared with traditional approach which first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention.

Detailed Description
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background: Coronary intervention using transradial approach is common worldwide. It is normally necessary to use one diagnostic catheter and guiding catheter in primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). It is unknown whether using a single guiding catheter for both nonculprit and culprit vessel angiography and intervention during transradial primary percutaneous coronary intervention (PCI) is feasible. objective:The aim of this study is to investigate the feasibility of using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI). This was a single-center, prospective, randomized study,patients with STEMI indicated for transradial primary PCI were randomized into two groups : group I consisted of patients who underwent coronary angiography and primary PCI by using a single guiding catheter.GroupII included patients who first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention. the primary Endpoints a.Cath Lab door to balloon time (C2B) the Secondary endpoints: Occurrence of major adverse cardiac events (MACE) during 6 months Cardiac death Target vessel related myocardial infarction Ischemia driven Target Vessel Revascularization (TVR) Ischemia driven Target Lesion Revascularization (TLR) Definite / probable stent thrombosis by ARC definition Number of catheters and wires used Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding) door to balloon time contrast consumption procedure time fluoroscopy time

Official Title
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Safety and Feasibility of Using a Single Transradial Guiding Catheter for Both Left and Right Coronary Angiography and Intervention in Patients With ST-segment Myocardial Infarction(RAPID)

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: guiding catheter
* Procedure: diagnostic catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be > 18 years of age. Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI. Symptoms ≥ 30 min and ≤12 hours Patient and treating interventional cardiologist agree for randomization. Patient provides written informed consent. Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach. Palpable radial or ulnar artery Previous experience of the operator with at least 100 cases of radial artery access within the past year Exclusion Criteria: Concurrent participation in other investigational study Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL. Absence of radial or ulnar artery pulsation Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy. Uncontrolled hypertension Prior CABG surgery Fibrinolytic therapy for current MI treatment patient have a life expectancy of <180days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: guiding catheter<br>a single transradial guiding catheter for coronary angiography and intervention in patients with STEMI | Procedure: guiding catheter<br>* using a single transradial guiding catheter for coronary angiography and intervention<br>|
| Active Comparator: Diagnostic catheter<br>Diagnostic catheter followed by guiding catheter selection for transradial primary PCI | Procedure: diagnostic catheter<br>* diagnostic for coronary angiography and guiding catheter selection for intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cath Lab door to balloon time (C2B) |  | 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac events (MACE) | Cardiac death Target vessel related myocardial infarction Ischemia driven Target Vessel Revascularization (TVR) Ischemia driven Target Lesion Revascularization (TLR) Definite / probable stent thrombosis by ARC definition | 180days | 
| Number of catheters and wires used |  | 24hours | 
| Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding) |  | 30days | 
| door to balloon time |  | 24hours | 
| contrast consumption |  | 24hours | 
| procedure time |  | 24hours | 
| fluoroscopy time |  | 24hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, Myocardial Infarction, Radial Artery, Catheters