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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ingibjorg Gudmundsdottir, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01878487
First received: May 1, 2013
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Acute ST Elevation Myocardial Infarction
Device: Thrombus aspiration (Intravascular Ultrasound catheter (Boston))

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INtra-Vascular Ultrasound Study of Export Thrombectomy in ST Elevation Myocardial Infarction Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Coronary artery lumen expansion after thrombus aspiration in primary percutaneous intervention. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01878487

Locations
United Kingdom
Department of Cardiology, Freeman Hospital
Newcastle, United Kingdom
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Ingibjorg Gudmundsdottir, Principal Investigator, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01878487     History of Changes
Other Study ID Numbers: 09/H0906/85
Study First Received: May 1, 2013
Last Updated: June 14, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Acute MI
Primary percutaneous coronary intervention
thrombus aspiration, IVUS

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014