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

July 14, 2020 updated by: Beijing Luhe Hospital

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 101149
        • Beijing luhe hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cath Lab door to balloon time (C2B)
Time Frame: 24hours
24hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major adverse cardiac events (MACE)
Time Frame: 180days
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
Number of catheters and wires used
Time Frame: 24hours
24hours
Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
Time Frame: 30days
30days
door to balloon time
Time Frame: 24hours
24hours
contrast consumption
Time Frame: 24hours
24hours
procedure time
Time Frame: 24hours
24hours
fluoroscopy time
Time Frame: 24hours
24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Luhe Hospital

Investigators

  • Study Director: Jincheng Guo, M.D., Beijing luhe hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

December 24, 2012

First Submitted That Met QC Criteria

December 24, 2012

First Posted (ESTIMATE)

January 2, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-7071-01 CHRDS
  • CHRDS (OTHER_GRANT: The capital health research and development of sepcial)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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