Condition category
Circulatory System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr O Kamp

ORCID ID

Contact details

VU University Medical Centre
Department of Cardiology
6D-120
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2244
o.kamp@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ULYSIS

Study hypothesis

The optimal treatment strategy in patients with Acute Myocardial Infarction (AMI) is immediate restoration of coronary blood flow. Although thrombolytic therapy is the most widely used therapy, Percutaneous Coronary Intervention (PCI) is the treatment of choice in AMI patients, however, its widespread use is hampered by limited availability of specialised facilities and trained staff. There is a need for simpler and low-risk methods for effective recanalisation of thrombosed arteries that can be initiated early in the disease process.

Recently, the application of ultrasound in combination with thrombolytic agents was found to enhance thrombus dissolution in vitro and in vivo. In vivo studies using thrombo-occlusive canine and rabbit models demonstrated that Ultrasound Contrast Agents (UCAs) enhance this thrombus dissolving effect of ultrasound, resulting in higher recanalisation rates of occluded arteries.

Hypothesis:
Under influence of ultrasound, UCAs enhance dissolution of thrombus in patients with acute ST-elevation myocardial infarction premedicated with aspirin and clopidogrel.

Ethics approval

Not provided at time of registration

Study design

Randomised, placebo controlled, parallel group, single blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute myocardial infarction

Intervention

After having received 150 - 325 mg aspirin and a loading dose of 300 mg clopidogrel, patients will be randomised to:
1. Ultrasound application with infusion of an ultrasound contrast agent, or
2. Control (infusion of saline without ultrasound application).

Immediately after ultrasound application, catheterisation will be performed.

Intervention type

Drug

Phase

Not Specified

Drug names

Aspirin and clopidogrel

Primary outcome measures

Comparison of the UCA-group and the control group with respect to:
1. Patency of the culprit coronary artery
2. Thrombolysis In Myocardial Infarction (TIMI)-flow
3. Corrected TIMI frame count
4. Myocardial blush grade

Secondary outcome measures

1. ST-segment resolution
2. Release of cardiac enzymes
3. Echocardiographic wall motion score index
4. Safety

Overall trial start date

01/10/2005

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 to 80 years
2. Diagnosed with acute myocardial infarction according to the criteria of the American College of Cardiology
3. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Previous myocardial infarction
2. Clinical instability
3. Pregnancy/breast feeding
4. Known pulmonary hypertension
5. Known allergy to Optison
6. Any reason judged by the investigators to hamper inclusion

Recruitment start date

01/10/2005

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

University/education

Website

http://www.vumc.nl/english/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes