Assessment of Lumen Expansion After Thrombus Extraction in Primary Percutaneous Coronary Intervention

Acute ST Elevation Myocardial Infarction Clinical Trial

— INVEST-MI  

Official title:

INtra-Vascular Ultrasound Study of Export Thrombectomy in ST Elevation Myocardial Infarction Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878487
• Other study ID #: 09/H0906/85
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: October 7, 2015
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: October 2015
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter in 40 patients during primary PCI.

Description:

Primary PCI has become the preferred therapy for ST-elevation acute myocardial infarction. The TAPAS trial data suggests that widespread adoption of manual thrombus aspiration may improve clinical outcomes for patients undergoing primary PCI.

Little data exists on the degree to which thrombus is removed during thrombectomy and how much thrombus remains with the potential for distal embolisation during stent deployment. The mechanism of lumen enlargement after thrombus aspiration is also unknown. Since angiography only provides an outline image of the vascular lumen, such questions cannot be adequately addressed by this modality alone.

The aim of this study is to use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter during primary PCI.

Hypotheses In this study we will assess 40 patients with STEMI. Primary PCI will be performed according to our hospital standard working protocol with thrombus aspiration and balloon dilatation of the culprit lesion if necessary prior to stent deployment. IVUS imaging will be undertaken prior to, and following, passage of the aspirations catheter to assess (1) initial and (2) residual thrombus volume. A third and final IVUS imaging run will be performed after stenting of the culprit lesion. IVUS analysis will be performed off-line to assess the lumen enlargement and volume of residual thrombus at each stage. All studies will be undertaken with the approval of the local Clinical Research Ethics.

Aspirated material will be collected and analyzed. Clinical markers such as Troponin release and left ventricular function will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. patients 18-75 years old with myocardial infarction with ST-segment elevation

2. symptoms of myocardial ischemia lasting more than 30 minutes

3. onset of symptoms within 12 hours of hospital presentation

4. ST-segment elevation of more than 0.1 mV in two or more leads on the ECG

Exclusion Criteria:

1. inability to obtain informed consent

2. use of fibrinolytic drug within 12 hours of presentation

3. comorbidity with anticipated life expectancy of < 6 months

4. cardiogenic shock on presentation

5. major bleeding diathesis

6. history of aspirin and clopidogrel intolerance

7. critical left main stem lesions

8. severe calcfic disease precluding safe passage of the imaging catheter

9. culprit lesion within saphenous vein grafts

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute ST Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Thrombus aspiration (Intravascular Ultrasound catheter (Boston))
There is a single arm in the study where all patients are undergoing primary percutaneous coronary intervention for an acute myocardial infarction. All patients will have an Intravascular Ultrasound three times: At baseline After thrombus aspiration with a thrombus extraction catheter After stent deployment We are however assessing the physiological response of patients having an acute myocardial infarction and this is not a test of the devices as such.

Locations

Country	Name	City	State
United Kingdom	Department of Cardiology, Freeman Hospital	Newcastle

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary artery lumen expansion after thrombus aspiration in primary percutaneous intervention.	Degree of thrombus extraction can be visualised immediately by intravascular ultrasound (IVUS) but detailed analysis will be carried out off-line and by histopathology of aspirated material within 4 months.	Day 1	No