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OpenTrials
Completed

NCT Number: NCT01759043

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Luhe hospital

Beijing, 101149, China

About this study

  • 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.
  • 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).
  • 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.
  • the primary Endpoints

a.Cath Lab door to balloon time (C2B)

  • the Secondary endpoints:
  • 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
  • Number of catheters and wires used
  • Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
  • door to balloon time
  • contrast consumption
  • procedure time
  • fluoroscopy time

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

guiding catheter

Procedure

using a single transradial guiding catheter for coronary angiography and intervention

diagnostic catheter

Procedure

diagnostic for coronary angiography and guiding catheter selection for intervention

Primary outcomes

  1. Cath Lab door to balloon time (C2B)

    Time frame: 24hours

Secondary outcomes

  1. 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

  2. Number of catheters and wires used

    Time frame: 24hours

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

    Time frame: 30days

  4. door to balloon time

    Time frame: 24hours

  5. contrast consumption

    Time frame: 24hours

  6. procedure time

    Time frame: 24hours

  7. fluoroscopy time

    Time frame: 24hours

Sponsors and collaborators

Lead sponsor

Beijing Luhe Hospital

Other

Registry information

Official study 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)

Acronym: RAPID

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 2, 2013
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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