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

ST Elevation Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04063345
• Other study ID #: SAHZJU CT015
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jun Jiang, MD, PhD
• Phone: +86-13588706891
• Email: drjayj[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• IVUS-guided PCI
Performing intravascular ultrasound before or/and after percutaneous intervention
• Angiography-guided PCI
Performing percutaneous intervention without intravascular ultrasound guidance

Locations

Country	Name	City	State
China	Second affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shanghai Chest Hospital, Taizhou Hospital, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MACE rate		2-3 years
Secondary	Target lesion revascularization (TLR) rate		2-3 years
Secondary	Target lesion failure (TLF) rate		2-3 years
Secondary	TVR rate		2-3 years
Secondary	Target vessel failure (TVF) rate		2-3 years
Secondary	MI (Q-wave and non-Q-wave) rat		2-3 years
Secondary	Cardiac death rate		2-3 years
Secondary	Non-cardiac death rate		2-3 years
Secondary	All death (cardiac and non-cardiovascular) rate		2-3 years
Secondary	Stent Thrombosis (ST) rate (ARC definite/probable)		2-3 years