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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring ST Elevation Myocardial Infarction，

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine at Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)

Angiography-Guided Primary Percutaneous Intervention (PCI)

Arm Description

Intravascular ultrasound guided surgery

Angiography-Guided guided surgery

Outcomes

Primary Outcome Measures

MACE rate at 12 months
major adverse cardiac event (MACE) rate at 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
TVR(Target Vessel Revascularization) at 12 months
defined as cardiac death, myocardial infarction at 12 months

Secondary Outcome Measures

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 )
TLR(3 years to evaluate each year)
TLR=Target Lesion Reascularization
TLF(3 years to evaluate each year)
TLF=Target Lesion Failure
TVR(3 years to evaluate each year)
TVR=Target Vessels Reascularization
TVF(3 years to evaluate each year)
TVF=Target Vessels Failure
MI (including:Q-wave and non-Q-wave)
Myocardialinfarction, Q-wave and non-Q-wave
All-cause death
All-cause death (including: cardiac and non cardiac)
Stent thrombosis
Stent Thrombosis (including:Sure/May stent thrombosis)

Full Information

First Posted
June 7, 2021
Last Updated
February 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang University, The Second People's Hospital of Hangzhou City in Zhejiang Province, The First People's Hospital of Tongxiang City in Zhejiang Province, The People's Hospital of Quzhou City in Zhejiang Province, The First People's Hospital of Ningbo City in Zhejiang Province, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Province People's Hospital, Taizhou First People's Hospital, The Central Hospital of Huzhou City in Zhejiang Province, Changxing People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04929158
Brief Title
Comparison of Clinical Outcomes of IVUS -Guided and Angiography-guided PCI in Patients With Acute STEMI
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang University, The Second People's Hospital of Hangzhou City in Zhejiang Province, The First People's Hospital of Tongxiang City in Zhejiang Province, The People's Hospital of Quzhou City in Zhejiang Province, The First People's Hospital of Ningbo City in Zhejiang Province, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Province People's Hospital, Taizhou First People's Hospital, The Central Hospital of Huzhou City in Zhejiang Province, Changxing People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
ST Elevation Myocardial Infarction，

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)
Arm Type
Experimental
Arm Description
Intravascular ultrasound guided surgery
Arm Title
Angiography-Guided Primary Percutaneous Intervention (PCI)
Arm Type
No Intervention
Arm Description
Angiography-Guided guided surgery
Intervention Type
Procedure
Intervention Name(s)
Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)
Other Intervention Name(s)
Boston Scientific，Opticross
Intervention Description
Preoperative criminal vascular assessment； The criminal vascular assessment after surgery
Primary Outcome Measure Information:
Title
MACE rate at 12 months
Description
major adverse cardiac event (MACE) rate at 12 months
Time Frame
up to 12 months
Title
Recurrence of myocardial infarction(including : Myocardialinfarction, Q-wave and non-Q-wave )at 12 months
Description
defined as cardiac death, myocardial infarction at 12 months
Time Frame
up to 12 months
Title
TVR(Target Vessel Revascularization) at 12 months
Description
defined as cardiac death, myocardial infarction at 12 months
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events(2-3 years annual assessment)
Description
MACE(including:Recurrence of angina pectoris, Acute Myocardial Infarction, Severe Arrhythmia, Heart Failure, Coronary Heart Disease Death )
Time Frame
3 years
Title
TLR(3 years to evaluate each year)
Description
TLR=Target Lesion Reascularization
Time Frame
3 years
Title
TLF(3 years to evaluate each year)
Description
TLF=Target Lesion Failure
Time Frame
3 years
Title
TVR(3 years to evaluate each year)
Description
TVR=Target Vessels Reascularization
Time Frame
3 years
Title
TVF(3 years to evaluate each year)
Description
TVF=Target Vessels Failure
Time Frame
3 years
Title
MI (including:Q-wave and non-Q-wave)
Description
Myocardialinfarction, Q-wave and non-Q-wave
Time Frame
3 years
Title
All-cause death
Description
All-cause death (including: cardiac and non cardiac)
Time Frame
3 years
Title
Stent thrombosis
Description
Stent Thrombosis (including:Sure/May stent thrombosis)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Dong
Phone
13858188861
Email
gemsangel@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianan Wang
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine at Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Dong, PhD
Phone
+13858188861
Email
gemsangel@163.com
First Name & Middle Initial & Last Name & Degree
Jianan Wang, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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