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

Myocardial Infarction Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759043
• Other study ID #: 2011-7071-01 CHRDS
• Secondary ID: CHRDS
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2020
• Source: Beijing Luhe Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• guiding catheter
using a single transradial guiding catheter for coronary angiography and intervention
• diagnostic catheter
diagnostic for coronary angiography and guiding catheter selection for intervention

Locations

Country	Name	City	State
China	Beijing Luhe hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Luhe Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cath Lab door to balloon time (C2B)		24hours
Secondary	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
Secondary	Number of catheters and wires used		24hours
Secondary	Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)		30days
Secondary	door to balloon time		24hours
Secondary	contrast consumption		24hours
Secondary	procedure time		24hours
Secondary	fluoroscopy time		24hours

External Links

•   Related Info