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Completed

NCT Number: NCT03272451

ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time

No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by PCI for the treatment of ST segment elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D) time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy time, cumulative air kerma(CAK) and dose area product(DAP).

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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, China

Loading trial locations.

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 transradial artery approach
  • Palpable radial artery.

Exclusion criteria

  • Concurrent participation in other investigational study
  • Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL
  • Absence of radial 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

culprit vessel intervention

Procedure

ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5

Traditional approach

Procedure

single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI

Primary outcomes

  1. door to device (D2D) time

    Time frame: 24hours

    time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use

Secondary outcomes

  1. puncture to device (P2D) time

    Time frame: 24hours

    time from radail artery puncture to first device(balloon,aspiration catheter or stent) use

  2. first medical contact to device (FMC2D) time

    Time frame: 24hours

    time from first medical contact to first device (balloon,aspiration catheter or stent) use.

  3. incidence of radial artery spasm

    Time frame: during the procedure (time from the guide catheter inserted to guide catheter removed)

    radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure

  4. incidence of radial artery occlusion

    Time frame: inhospital (an expected average of 5 days),30day,12month

    the absence of palpable radial artery pulsation confirmed by echocardiogram

  5. fluoroscopy time

    Time frame: 1 hour

    recorded on the machine

  6. cumulative air kerma(CAK) and dose area product(DAP).

    Time frame: 1 hour

    recorded on the machine

Other outcomes

  1. MACE

    Time frame: 12 month

    major advance cardiac event (MACE)including cardiacdeath, myocardial infarction (MI) and target vessel revascularization (TVR)

Sponsors and collaborators

Lead sponsor

Beijing Luhe Hospital

Other

Registry information

Official study title

ECG-guided Immediate pRimAry Percutaneous Coronary Intervention for Culprit Vessel Using a Transradial Single Guiding Catheter to Reduce Door to Device Time: RAPID II Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 5, 2017
Registry last updated
Jun 1, 2022

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

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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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