Assessment of Lumen Expansion After Thrombus Extraction in Primary Percutaneous Coronary Intervention (INVEST-MI)

October 7, 2015 updated by: Newcastle-upon-Tyne Hospitals NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle, United Kingdom
        • Department of Cardiology, Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Only one arm
All patients will receive the same treatment, i.e. there is no randomization. There is therefore only one arm, all patients will by treated as per standard practice with thrombus aspiration and stenting as required, the lumen size of the vessel will be assessed with intravascular ultrasound at baseline, after thrombus aspiration and after stenting.
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:

  1. At baseline
  2. After thrombus aspiration with a thrombus extraction catheter
  3. 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.

Other Names:
  • Export thrombus aspiration cathether
  • Intravascular Ultrasound catheter (Boston)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary artery lumen expansion after thrombus aspiration in primary percutaneous intervention.
Time Frame: Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/H0906/85

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute ST Elevation Myocardial Infarction

Clinical Trials on Thrombus aspiration (Intravascular Ultrasound catheter (Boston))

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe