NCT00955136

Brief Summary

The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2010

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

August 5, 2009

Last Update Submit

August 10, 2023

Conditions

Acute Coronary SyndromeMyocardial Infarction

Keywords

ST elevated myocardial infarctionAcute coronary syndromeMRX 801Echocardiography

Outcome Measures

Primary Outcomes (1)

  • Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period.

    Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period.

    6 weeks

Study Arms (1)

High MI impulses, myocardial infarction, echocardiography

EXPERIMENTAL

Using the transthoracic three dimensional imaging probe, low mechanical index (MI) will examine wall motion. Intermittent high MI impulses will be administered over the microvasculature where there are wall motion abnormalities using an imaging plan that best aligns itself with the risk area. One vial of MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses.

Device: Use of intermittent high MI impulses during echocardiogram

Interventions

Use of intermittent high MI impulses during echocardiogramDEVICE

Using the transthoracic three dimensional imaging probe, low mechanical index (MI) will examine wall motion. Intermittent high MI impulses will be administered over the microvasculature where there are wall motion abnormalities using an imaging plan that best aligns itself with the risk area. One vial of MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses.

High MI impulses, myocardial infarction, echocardiography

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age ≥ 30 years.
  • Chest Pain occurring lasting less than six hours from onset, and EKG evidence of an acute ST segment elevation myocardial infarction.

You may not qualify if:

  • Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
  • Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
  • Life expectancy of less than two months or terminally ill.
  • Heart transplant recipient, hypertrophic cardiomyopathy, severe valvular disease, acute myo- or pericarditis.
  • Contraindication to Heart Catheterization
  • Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors or aspirin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Thomas R Porter, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

July 1, 2009

Primary Completion

January 25, 2010

Study Completion

January 25, 2010

Last Updated

August 14, 2023

Record last verified: 2023-08