Clinical trial NCT01759043: Safety and Feasibility of Using a Single Transradial Guiding Catheter for Primary PCI
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: coronary artery disease
Myocardial Infarction
Radial Artery
Catheters
Lead sponsor: Beijing Luhe Hospital
Sponsor class: OTHER
First posted: 2013-01-02
Enrollment: 360
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: 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: 1. 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.
2. 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).
3. 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.
4. the primary Endpoints

   a.Cath Lab door to balloon time (C2B)
5. the Secondary endpoints:

   1. 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
   2. Number of catheters and wires used
   3. Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
   4. door to balloon time
   5. contrast consumption
   6. procedure time
   7. fluoroscopy time

Eligibility criteria: 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

Primary outcomes:
measure: Cath Lab door to balloon time (C2B)
timeFrame: 24hours
Secondary outcomes:
measure: major adverse cardiac events (MACE)
timeFrame: 180days
measure: Number of catheters and wires used
timeFrame: 24hours
measure: Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
timeFrame: 30days
measure: door to balloon time
timeFrame: 24hours
measure: contrast consumption
timeFrame: 24hours
measure: procedure time
timeFrame: 24hours
measure: fluoroscopy time
timeFrame: 24hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe hospital
Study officials:
affiliation: Beijing Luhe Hospital
name: Jincheng Guo, M.D.
role: STUDY_DIRECTOR
References:
citation: Guo J, Chen W, Wang G, Liu Z, Hao M, Xu M, Zhu F. Safety and Efficacy of Using a Single Transradial MAC Guiding Catheter for Coronary Angiography and Intervention in Patients with ST Elevation Myocardial Infarction. J Interv Cardiol. 2017 Feb;30(1):33-42. doi: 10.1111/joic.12346. Epub 2016 Oct 25.