Comparison of Clinical Outcomes of IVUS -Guided and Angiography-guided PCI in Patients With Acute STEMI

Comparison of Clinical Outcomes of Intravascular Ultrasound (IVUS) -Guided and Angiography-Guided Primary Percutaneous Intervention (PCI) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI)

To compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI

Study Overview

• Status: Available
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)

Detailed Description

This study is a prospective, multicenter, randomized controlled trial, led by the second hospital affiliated to zhejiang university school of medicine, A total of 10 hospitals in zhejiang province interventional cardiovascular center to participate in, plan to recruit 200 STEMI patients.

Subjects according to the proportion of 1:1 were randomly allocated to two treatment groups.(Experimental group (IVUS) steering group or control group (imaging) steering group.) Plan 10 centers in 200 men and women aged 18 and older patients, according to the American heart association and the United States The college of cardiology interventional treatment guidelines for the participants.

Each center recruiting number does not exceed 40% of the total plan recruitment.

• Study Type: Expanded Access
• Expanded Access Type: Treatment IND/Protocol
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Available
      • 2nd Affiliated Hospital, School of Medicine at Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Clinical Inclusion (CI) Criteria: CI. Age > 18 years C2. Onset of STEMI > 30 minutes, but < 12 hours C3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG C4. Willing and able to provide informed consent

• Angiographic Inclusion (AI) Criteria (visual estimate) AI1. Having at least one infarct-related coronary artery of which
• the Culprit lesion is suitable for stenting
• the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm
• the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing AI2. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation

Exclusion Criteria:

• Clinical Exclusion (CE) Criteria CE1. Contraindicating to any concomitant study medications CE2. Having cardiogenic shock with hemodynamic instability CE3. A history of bleeding diathesis or known coagulopathy CE4. 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 CE5. Planned surgery which may cause discontinuation of ADP-receptor antagonist CE6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year CE7. Repeated MI within 7 days of hospitalization for acute MI
• Angiographic Exclusion (AE) Criteria (visual estimate) AE1. Bifurcated lesion unable to identify the culprit lesion AE2. The culprit lesion is located in the left main artery. AE3. Diffusive lesions without distinguishable culprit lesion AE4. Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis AE5. Likely CABG procedure within 30 days

Study Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI); Intravascular ultrasound guided surgery	Procedure: Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI); Preoperative criminal vascular assessment； The criminal vascular assessment after surgery; Other Names: Angiography-guided Primary Percutaneous Intervention (PCI)
No Intervention: Angiography-Guided Primary Percutaneous Intervention (PCI); Angiography-Guided guided surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE rate at 12 months	major adverse cardiac event (MACE) rate at 12 months	up to 12 months
Recurrence of myocardial infarction(including : Myocardialinfarction, Q-wave and non-Q-wave )at 12 months	defined as cardiac death, myocardial infarction at 12 months	up to 12 months
TVR(Target Vessel Revascularization) at 12 months	defined as cardiac death, myocardial infarction at 12 months	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events(2-3 years annual assessment)	MACE(including:Recurrence of angina pectoris, Acute Myocardial Infarction, Severe Arrhythmia, Heart Failure, Coronary Heart Disease Death )	3 years
TLR(3 years to evaluate each year)	TLR=Target Lesion Reascularization	3 years
TLF(3 years to evaluate each year)	TLF=Target Lesion Failure	3 years
TVR(3 years to evaluate each year)	TVR=Target Vessels Reascularization	3 years
TVF(3 years to evaluate each year)	TVF=Target Vessels Failure	3 years
MI (including:Q-wave and non-Q-wave)	Myocardialinfarction, Q-wave and non-Q-wave	3 years
All-cause death	All-cause death (including: cardiac and non cardiac)	3 years
Stent thrombosis	Stent Thrombosis (including:Sure/May stent thrombosis)	3 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Zhejiang University; First Affiliated Hospital of Wenzhou Medical University; Taizhou First People's Hospital; Changxing People's Hospital
• Investigators: Principal Investigator: Jianan Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start: June 8, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ST Elevation Myocardial Infarction，
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: clinical 2020-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No