NCT01759043

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 2, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

December 24, 2012

Last Update Submit

July 14, 2020

Conditions

Myocardial Infarction

Keywords

coronary artery diseaseMyocardial InfarctionRadial ArteryCatheters

Outcome Measures

Primary Outcomes (1)

  • Cath Lab door to balloon time (C2B)

    24hours

Secondary Outcomes (7)

  • major adverse cardiac events (MACE)

    180days

  • Number of catheters and wires used

    24hours

  • Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)

    30days

  • door to balloon time

    24hours

  • contrast consumption

    24hours

  • +2 more secondary outcomes

Study Arms (2)

guiding catheter

EXPERIMENTAL

a single transradial guiding catheter for coronary angiography and intervention in patients with STEMI

Procedure: guiding catheter

Diagnostic catheter

ACTIVE COMPARATOR

Diagnostic catheter followed by guiding catheter selection for transradial primary PCI

Procedure: diagnostic catheter

Interventions

guiding catheterPROCEDURE

using a single transradial guiding catheter for coronary angiography and intervention

guiding catheter
diagnostic catheterPROCEDURE

diagnostic for coronary angiography and guiding catheter selection for intervention

Diagnostic catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Luhe hospital

Beijing, 101149, China

Location

Related 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. doi: 10.1111/joic.12346. Epub 2016 Oct 25.

    PMID: 27781297RESULT

Related Links

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Jincheng Guo, M.D.

    Beijing Luhe Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2012

First Posted

January 2, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2014

Study Completion

December 1, 2015

Last Updated

July 15, 2020

Record last verified: 2020-07

Locations

CN(1)