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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cath Lab door to balloon time (C2B)
Time Frame: 24hours
24hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Luhe Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-7071-01 CHRDS
  • CHRDS (OTHER_GRANT: The capital health research and development of sepcial)

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