Ultrasound contrast agents to facilitate sonothrombolysis in patients with acute myocardial infarction
| ISRCTN | ISRCTN32486185 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32486185 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr O Kamp
Scientific
Scientific
VU University Medical Centre
Department of Cardiology, 6D-120
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2244 |
|---|---|
| o.kamp@vumc.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group, single blinded multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Ultrasound contrast agents to facilitate sonothrombolysis in patients with acute myocardial infarction |
| Study acronym | ULYSIS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aspirin and clopidogrel |
| Primary outcome measure | 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 study start date | 01/10/2005 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
VU University Medical Centre (The Netherlands)
University/education
University/education
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Website | http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 08/03/2011 | 20/08/2021 | Yes | No | |
| Results article | 01/02/2012 | 20/08/2021 | Yes | No |
Editorial Notes
20/08/2021: Publication reference added.
