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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Beijing Luhe Hospital
Sponsor:
Information provided by (Responsible Party):
Beijing Luhe Hospital
ClinicalTrials.gov Identifier:
NCT01759043
First received: December 24, 2012
Last updated: July 16, 2014
Last verified: July 2014
  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:
  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. Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma]
    3. Number of catheters and wires used
    4. Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
    5. door to balloon time
    6. contrast consumption
    7. procedure time
    8. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 16, 2014
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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014