NCT04063345

Brief Summary

To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
2.1 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

August 19, 2019

Last Update Submit

January 26, 2021

Conditions

ST Elevation Myocardial Infarction

Keywords

STEMIIntravascular ultrasoundAngiographyPrimary percutaneous intervention

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac event (MACE) rate

    Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR)

    1 year

Secondary Outcomes (10)

  • MACE rate

    2-3 years

  • Target lesion revascularization (TLR) rate

    2-3 years

  • Target lesion failure (TLF) rate

    2-3 years

  • TVR rate

    2-3 years

  • Target vessel failure (TVF) rate

    2-3 years

  • +5 more secondary outcomes

Study Arms (2)

IVUS-guided PCI

EXPERIMENTAL

Percutaneous intervention under IVUS-guidance

Procedure: IVUS-guided PCI

Angiography-guided PCI

ACTIVE COMPARATOR

Percutaneous intervention under angiograhy-guidance only

Procedure: Angiography-guided PCI

Interventions

IVUS-guided PCIPROCEDURE

Performing intravascular ultrasound before or/and after percutaneous intervention

IVUS-guided PCI
Angiography-guided PCIPROCEDURE

Performing percutaneous intervention without intravascular ultrasound guidance

Angiography-guided PCI

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Onset of STEMI \> 30 minutes, but \< 12 hours
  • ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG
  • Willing and able to provide informed consent
  • Having at least one infarct-related coronary artery, of which (1) the Culprit lesion is suitable for stenting (2) the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm (3) the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing
  • No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation

You may not qualify if:

  • Contraindicating to any concomitant study medications
  • Having cardiogenic shock with hemodynamic instability
  • A history of bleeding diathesis or known coagulopathy
  • A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count \< 100,000 /mm3 or Hb \< 10 g/dL
  • Planned surgery which may cause discontinuation of ADP-receptor antagonist
  • Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
  • Repeated MI within 7 days of hospitalization for acute MI
  • Bifurcated lesion unable to identify the culprit lesion
  • The culprit lesion is located in the left main artery
  • Diffusive lesions without distinguishable culprit lesion
  • Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis
  • Likely CABG procedure within 30 days
  • Renal failure requiring or during dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jian-an Wang, MD, PhD

    Second Affiliated Hospital of Zhejiang University, School of Medicine

    STUDY CHAIR

Central Study Contacts

Jun Jiang, MD, PhD

CONTACT

+86-13588706891drjayj@hotmail.com

Liang Dong, MD, PhD

CONTACT

+86-13858188861chenhaibo1030@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 21, 2019

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2023

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

CN(1)