Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction (LOVEinSTEMI)

A Prospective, Open Label, Multicenter and Randomized Study of Clinical Outcomes of Intravascular Ultrasound -Guided and Angiography-Guided Primary Percutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction

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

Study Overview

• Status: Not yet recruiting
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: IVUS-guided PCI; Procedure: Angiography-guided PCI

Detailed Description

Intravascular ultrasound (IVUS) has been increasingly used as a guide for percutaneous coronary intervention (PCI) during elective as well as emergent clinical scenario. Recent small number randomized studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of IVUS-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization.

There are sparse data available on the clinical impact of IVUS-guided PCI in the setting of acute myocardial infarction (AMI) and its use remains a matter of controversy as shown by previous studies. This study is to examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction (STEMI).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jun Jiang, MD, PhD; Phone Number: +86-13588706891; Email: drjayj@hotmail.com
• Study Contact Backup: Name: Liang Dong, MD, PhD; Phone Number: +86-13858188861; Email: chenhaibo1030@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital ZheJiang University School of Medicine
      • Contact: Jun Jiang, MD, PhD; Phone Number: +86-13588706891; Email: drjayj@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical inclusion criteria:

  1. Age > 18 years
  2. Onset of STEMI > 30 minutes, but < 12 hours
  3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG
  4. Willing and able to provide informed consent

• Angiographic inclusion criteria:

  1. 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
  2. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation

Exclusion Criteria:

• Clinical exclusion criteria:

  1. Contraindicating to any concomitant study medications
  2. Having cardiogenic shock with hemodynamic instability
  3. A history of bleeding diathesis or known coagulopathy
  4. 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
  5. Planned surgery which may cause discontinuation of ADP-receptor antagonist
  6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
  7. Repeated MI within 7 days of hospitalization for acute MI

• Anigographic Exclusion Criteria:

  1. Bifurcated lesion unable to identify the culprit lesion
  2. The culprit lesion is located in the left main artery
  3. Diffusive lesions without distinguishable culprit lesion
  4. Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis
  5. Likely CABG procedure within 30 days
  6. Renal failure requiring or during dialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IVUS-guided PCI; Percutaneous intervention under IVUS-guidance	Procedure: IVUS-guided PCI; Performing intravascular ultrasound before or/and after percutaneous intervention
ACTIVE_COMPARATOR: Angiography-guided PCI; Percutaneous intervention under angiograhy-guidance only	Procedure: Angiography-guided PCI; Performing percutaneous intervention without intravascular ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
MI (Q-wave and non-Q-wave) rat	2-3 years
Cardiac death rate	2-3 years
Non-cardiac death rate	2-3 years
All death (cardiac and non-cardiovascular) rate	2-3 years
Stent Thrombosis (ST) rate (ARC definite/probable)	2-3 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Shanghai Chest Hospital; Second Affiliated Hospital of Wenzhou Medical University; First Affiliated Hospital of Wenzhou Medical University; Ningbo No. 1 Hospital; Taizhou Hospital; The First Affiliated Hospital of Xiamen University
• Investigators: Study Chair: Jian-an Wang, MD, PhD, Second Affiliated Hospital of Zhejiang University, School of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: STEMI; Intravascular ultrasound; Angiography; Primary percutaneous intervention
• 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: SAHZJU CT015

Drug and device information, study documents

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