Myocardial InfarctionNCT02299609
Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI
A study testing Ultrasound beams Philips HD11 XE® in people with Myocardial Infarction and ST Elevation Myocardial Infarction, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Successfully perfused STEMI patients will receive routine transthoracic echocardiography qid for 4 days or placebo. Myocardial function and infarct size will be evaluated at 3 and 6 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, ST Elevation Myocardial Infarction
- What is being tested?
- Ultrasound beams Philips HD11 XE®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients presenting within 12 hours of their first ST- elevation myocardial infarction that is successfully reperfused; and completed baseline echocardiographic evaluation and accepted participation in the study
Who cannot join
- Patients:
- With prior ST- elevation myocardial infarction
- Patients presenting >12hrs
- Not successfully reperfused
- Not completed baseline ECHO evaluation,
- Not accepting participation in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University, Faculty of Medicine
Sakarya, 54290
Ramazan Akdemir, MD, 00905336020700, rakdemir@yahoo.com
About this study
Official title: Therapeutic Effect of Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI
Successfully perfused STEMI patients will receive routine transthoracic echocardiography qid for 4 days or placebo. Myocardial function and infarct size will be evaluated at 3 and 6 months.
Read the detailed description
Patients who had acute STEMI and successfully reperfused by either thrombolytic therapy or primary angioplasty and stenting will be included this study.
A basal routine echocardiography will be obtained in all patients after reperfusion therapy. Thereafter, patients will be divided into two groups: 1.Treatment group will receive transthoracic echocardiography using Philips HD11 XE ® for 30 minutes qid for 4 days. 2. Placebo group will have the same Philips HD11 XE ® echo transducer applied for the same time and duration on their chest but with the ultrasound turned-off. Detailed left and right ventricle function as well as performance index and stress-strain imaging will be obtained and analyzed at 3 and 6 months.
- Being tested
- Ultrasound beams Philips HD11 XE®
- Keywords
- C14.280.647.500
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound beams Philips HD11 XE®Other
Ultrasound beams used during standard echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Beam Receiver | Active comparator | Philips HD11 XE® 30 min qid x 4 days Receives: Other: Ultrasound beams Philips HD11 XE® |
| Beam Non-Receiver | Sham comparator | Philips HD11 XE® (ultrasound turned-off) 30 min qid x 4 days Receives: Other: Ultrasound beams Philips HD11 XE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in left ventricular function
Ultrasound beams during echocardiography application expected to ameliorate the left ventricle function
Measured: At 3 and 6 months
Secondary outcomes (1)
Decrease in infarct size
Ultrasound beams during echocardiography application expected to decrease infarct size
Measured: At 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Akdemir, Sakarya University
- Investigators
- Ramazan Akdemir, MD, Study chair, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299609
- Sponsor's protocol ID
- CCTSAU1400
- Status last verified
- Nov 2014
- First submitted
- 17 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ling ZY, Shu SY, Zhong SG, Luo J, Su L, Liu ZZ, Lan XB, Yuan GB, Zheng YY, Ran HT, Wang ZG, Yin YH. Ultrasound targeted microbubble destruction promotes angiogenesis and heart function by inducing myocardial microenvironment change. Ultrasound Med Biol. 2013 Nov;39(11):2001-10. doi: 10.1016/j.ultrasmedbio.2013.06.003. Epub 2013 Aug 19.
PubMed 23969167Nazer B, Gerstenfeld EP, Hata A, Crum LA, Matula TJ. Cardiovascular applications of therapeutic ultrasound. J Interv Card Electrophysiol. 2014 Apr;39(3):287-94. doi: 10.1007/s10840-013-9845-z. Epub 2013 Dec 3.
PubMed 24297498
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI
- ClinicalTrials.gov ID
- NCT02299609
- Acronym / sponsor ID
- CCTSAU1400
- Keywords
- C14.280.647.500
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Successfully perfused STEMI patients will receive routine transthoracic echocardiography qid for 4 days or placebo. Myocardial function and infarct size will be evaluated at 3 and 6 months.
Detailed description
Patients who had acute STEMI and successfully reperfused by either thrombolytic therapy or primary angioplasty and stenting will be included this study.
A basal routine echocardiography will be obtained in all patients after reperfusion therapy. Thereafter, patients will be divided into two groups: 1.Treatment group will receive transthoracic echocardiography using Philips HD11 XE ® for 30 minutes qid for 4 days. 2. Placebo group will have the same Philips HD11 XE ® echo transducer applied for the same time and duration on their chest but with the ultrasound turned-off. Detailed left and right ventricle function as well as performance index and stress-strain imaging will be obtained and analyzed at 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beam Receiver | Active comparator | Other: Ultrasound beams Philips HD11 XE®Philips HD11 XE® 30 min qid x 4 days |
| Beam Non-Receiver | Sham comparator | Other: Ultrasound beams Philips HD11 XE®Philips HD11 XE® (ultrasound turned-off) 30 min qid x 4 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients presenting within 12 hours of their first ST- elevation myocardial infarction that is successfully reperfused; and completed baseline echocardiographic evaluation and accepted participation in the study
Key exclusion criteria (6 listed)
- With prior ST- elevation myocardial infarction
- Patients presenting >12hrs
- Not successfully reperfused
- Not completed baseline ECHO evaluation,
- Not accepting participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound beams Philips HD11 XE®Ultrasound beams used during standard echocardiography | Other | Beam Non-Receiver, Beam Receiver |
Primary outcome
Increase in left ventricular function
Time frame: At 3 and 6 months
Ultrasound beams during echocardiography application expected to ameliorate the left ventricle function
1 secondary outcome
Decrease in infarct size
Time frame: At 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Results publication: PubMed 23969167Ling ZY, Shu SY, Zhong SG, Luo J, Su L, Liu ZZ, Lan XB, Yuan GB, Zheng YY, Ran HT, Wang ZG, Yin YH. Ultrasound targeted microbubble destruction promotes angiogenesis and heart function by inducing myocardial microenvironment change. Ultrasound Med Biol. 2013 Nov;39(11):2001-10. doi: 10.1016/j.ultrasmedbio.2013.06.003. Epub 2013 Aug 19.
- Results publication: PubMed 24297498Nazer B, Gerstenfeld EP, Hata A, Crum LA, Matula TJ. Cardiovascular applications of therapeutic ultrasound. J Interv Card Electrophysiol. 2014 Apr;39(3):287-94. doi: 10.1007/s10840-013-9845-z. Epub 2013 Dec 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramazan Akdemir, MD study chair
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound beams Philips HD11 XE® in people with Myocardial Infarction and ST Elevation Myocardial Infarction, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramazan Akdemir, MD (00905336020700, rakdemir@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in left ventricular function (time frame: At 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299609, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.