Safety and Feasibility of Using a Single Transradial Guiding Catheter for Primary PCI (RAPID)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
guiding catheter
diagnostic catheter
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring coronary artery disease, Myocardial Infarction, Radial Artery, Catheters
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
Sites / Locations
- Beijing Luhe hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
guiding catheter
Diagnostic catheter
Arm Description
a single transradial guiding catheter for coronary angiography and intervention in patients with STEMI
Diagnostic catheter followed by guiding catheter selection for transradial primary PCI
Outcomes
Primary Outcome Measures
Cath Lab door to balloon time (C2B)
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01759043
Brief Title
Safety and Feasibility of Using a Single Transradial Guiding Catheter for Primary PCI
Acronym
RAPID
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Luhe Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
coronary artery disease, Myocardial Infarction, Radial Artery, Catheters
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
guiding catheter
Arm Type
Experimental
Arm Description
a single transradial guiding catheter for coronary angiography and intervention in patients with STEMI
Arm Title
Diagnostic catheter
Arm Type
Active Comparator
Arm Description
Diagnostic catheter followed by guiding catheter selection for transradial primary PCI
Intervention Type
Procedure
Intervention Name(s)
guiding catheter
Intervention Description
using a single transradial guiding catheter for coronary angiography and intervention
Intervention Type
Procedure
Intervention Name(s)
diagnostic catheter
Intervention Description
diagnostic for coronary angiography and guiding catheter selection for intervention
Primary Outcome Measure Information:
Title
Cath Lab door to balloon time (C2B)
Time Frame
24hours
Secondary Outcome Measure Information:
Title
major adverse cardiac events (MACE)
Description
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
Time Frame
180days
Title
Number of catheters and wires used
Time Frame
24hours
Title
Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
Time Frame
30days
Title
door to balloon time
Time Frame
24hours
Title
contrast consumption
Time Frame
24hours
Title
procedure time
Time Frame
24hours
Title
fluoroscopy time
Time Frame
24hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jincheng Guo, M.D.
Organizational Affiliation
Beijing Luhe Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Luhe hospital
City
Beijing
ZIP/Postal Code
101149
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
27781297
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/27781297/
Description
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Safety and Feasibility of Using a Single Transradial Guiding Catheter for Primary PCI
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