Back to resultsLong-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction (LOVEinSTEMI)
Primary Purpose
ST Elevation Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IVUS-guided PCI
Angiography-guided PCI
Sponsored by
About this trial
This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring STEMI, Intravascular ultrasound, Angiography, Primary percutaneous intervention
Eligibility Criteria
Inclusion Criteria:
Clinical inclusion criteria:
- 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
Angiographic inclusion criteria:
- 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
Exclusion Criteria:
Clinical exclusion criteria:
- 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
Anigographic Exclusion Criteria:
- 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
Sites / Locations
- Second affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IVUS-guided PCI
Angiography-guided PCI
Arm Description
Percutaneous intervention under IVUS-guidance
Percutaneous intervention under angiograhy-guidance only
Outcomes
Primary Outcome Measures
Major adverse cardiac event (MACE) rate
Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR)
Secondary Outcome Measures
MACE rate
Target lesion revascularization (TLR) rate
Target lesion failure (TLF) rate
TVR rate
Target vessel failure (TVF) rate
MI (Q-wave and non-Q-wave) rat
Cardiac death rate
Non-cardiac death rate
All death (cardiac and non-cardiovascular) rate
Stent Thrombosis (ST) rate (ARC definite/probable)
Full Information
NCT ID
NCT04063345
First Posted
August 19, 2019
Last Updated
January 26, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Ningbo No. 1 Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Xiamen University, Shanghai Chest Hospital, Taizhou Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04063345
Brief Title
Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
Acronym
LOVEinSTEMI
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Ningbo No. 1 Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Xiamen University, Shanghai Chest Hospital, Taizhou Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
STEMI, Intravascular ultrasound, Angiography, Primary percutaneous intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IVUS-guided PCI
Arm Type
Experimental
Arm Description
Percutaneous intervention under IVUS-guidance
Arm Title
Angiography-guided PCI
Arm Type
Active Comparator
Arm Description
Percutaneous intervention under angiograhy-guidance only
Intervention Type
Procedure
Intervention Name(s)
IVUS-guided PCI
Intervention Description
Performing intravascular ultrasound before or/and after percutaneous intervention
Intervention Type
Procedure
Intervention Name(s)
Angiography-guided PCI
Intervention Description
Performing percutaneous intervention without intravascular ultrasound guidance
Primary Outcome Measure Information:
Title
Major adverse cardiac event (MACE) rate
Description
Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
MACE rate
Time Frame
2-3 years
Title
Target lesion revascularization (TLR) rate
Time Frame
2-3 years
Title
Target lesion failure (TLF) rate
Time Frame
2-3 years
Title
TVR rate
Time Frame
2-3 years
Title
Target vessel failure (TVF) rate
Time Frame
2-3 years
Title
MI (Q-wave and non-Q-wave) rat
Time Frame
2-3 years
Title
Cardiac death rate
Time Frame
2-3 years
Title
Non-cardiac death rate
Time Frame
2-3 years
Title
All death (cardiac and non-cardiovascular) rate
Time Frame
2-3 years
Title
Stent Thrombosis (ST) rate (ARC definite/probable)
Time Frame
2-3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical inclusion criteria:
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
Angiographic inclusion criteria:
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
Exclusion Criteria:
Clinical exclusion criteria:
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
Anigographic Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Jiang, MD, PhD
Phone
+86-13588706891
Email
drjayj@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Dong, MD, PhD
Phone
+86-13858188861
Email
chenhaibo1030@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-an Wang, MD, PhD
Organizational Affiliation
Second Affiliated Hospital of Zhejiang University, School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Second affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Jiang, MD, PhD
Phone
+86-13588706891
Email
drjayj@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
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