Safety and Feasibility of Using a Single Transradial Guiding Catheter for Primary PCI (RAPID)
This study is currently recruiting participants.
Verified December 2012 by Beijing Luhe Hospital
Sponsor:
Beijing Luhe Hospital
Information provided by (Responsible Party):
Beijing Luhe Hospital
ClinicalTrials.gov Identifier:
NCT01759043
First received: December 24, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Myocardial Infarction |
Procedure: guiding catheter Procedure: diagnostic catheter |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Beijing Luhe Hospital:
Primary Outcome Measures:
- Cath Lab door to balloon time (C2B) [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- major adverse cardiac events (MACE) [ Time Frame: 180days ] [ Designated as safety issue: Yes ]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
- b.Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma] [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]
- Number of catheters and wires used [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]
- Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding) [ Time Frame: 30days ] [ Designated as safety issue: Yes ]
- door to balloon time [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]
- contrast consumption [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]
- procedure time [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]
- fluoroscopy time [ Time Frame: 24hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 360 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: guiding catheter
a single transradial guiding catheter for coronary angiography and intervention in patients with STEMI
|
Procedure: guiding catheter
using a single transradial guiding catheter for coronary angiography and intervention
|
|
Active Comparator: Diagnostic catheter
Diagnostic catheter followed by guiding catheter selection for transradial primary PCI
|
Procedure: diagnostic catheter
diagnostic for coronary angiography and 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
- Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma]
- 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Cardiogenic shock
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759043
Contacts
| Contact: Jincheng Guo, M.D. | 8610-69543901 ext 2588 | guojcmd@126.com |
Locations
| China | |
| Beijing Luhe hospital | Recruiting |
| Beijing, China, 101149 | |
| Contact: Jincheng Guo, M.D. 8610-69543901 ext 2588 guojcmd@126.com | |
| Principal Investigator: Jincheng Guo, M.D. | |
Sponsors and Collaborators
Beijing Luhe Hospital
Investigators
| Study Director: | Jincheng Guo, M.D. | Beijing Luhe Hospital |
More Information
No publications provided
| Responsible Party: | Beijing Luhe Hospital |
| ClinicalTrials.gov Identifier: | NCT01759043 History of Changes |
| Other Study ID Numbers: | 2011-7071-01 CHRDS, CHRDS |
| Study First Received: | December 24, 2012 |
| Last Updated: | December 24, 2012 |
| Health Authority: | China: Beijing Municipal Science and Technology Commission |
Keywords provided by Beijing Luhe Hospital:
|
coronary artery disease Myocardial Infarction Radial Artery Catheters |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013