NCT03272451

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

February 10, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

2.4 years

First QC Date

August 30, 2017

Last Update Submit

May 31, 2022

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • door to device (D2D) time

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

    24hours

Secondary Outcomes (6)

  • puncture to device (P2D) time

    24hours

  • first medical contact to device (FMC2D) time

    24hours

  • incidence of radial artery spasm

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

  • incidence of radial artery occlusion

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

  • fluoroscopy time

    1 hour

  • +1 more secondary outcomes

Other Outcomes (1)

  • MACE

    12 month

Study Arms (2)

culprit vessel intervention

EXPERIMENTAL

culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter

Procedure: culprit vessel intervention

traditional approach

ACTIVE COMPARATOR

complete coronary angiography followed by guiding catheter selection for culprit vessel PCI

Procedure: traditional approach

Interventions

culprit vessel interventionPROCEDURE

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

culprit vessel intervention
traditional approachPROCEDURE

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

traditional approach

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 transradial artery approach
  • Palpable radial artery.

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 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 (2)

Beijing Luhe hospital

Beijing, 101149, China

Location

Beijing Luhe hospital

Beijing, China

Location

Related Publications (1)

  • Guo J, Wang G, Li Z, Liu Z, Wang Y, Wang S, Wang Y, Wu Y, Wang H, Wang Y, Zhang L, Hua Q. Culprit vessel revascularization first with primary use of a dedicated transradial guiding catheter to reduce door to balloon time in primary percutaneous coronary intervention. Front Cardiovasc Med. 2022 Oct 28;9:1022488. doi: 10.3389/fcvm.2022.1022488. eCollection 2022.

    PMID: 36386357DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 5, 2017

Study Start

February 10, 2017

Primary Completion

July 15, 2019

Study Completion

July 31, 2019

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

CN(2)