MedDataX Logo

Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

NCT ID: NCT02299609

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction ST Elevation Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beam Receiver

Philips HD11 XE® 30 min qid x 4 days

Group Type ACTIVE_COMPARATOR

Ultrasound beams Philips HD11 XE®

Intervention Type OTHER

Ultrasound beams used during standard echocardiography

Beam Non-Receiver

Philips HD11 XE® (ultrasound turned-off) 30 min qid x 4 days

Group Type SHAM_COMPARATOR

Ultrasound beams Philips HD11 XE®

Intervention Type OTHER

Ultrasound beams used during standard echocardiography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound beams Philips HD11 XE®

Ultrasound beams used during standard echocardiography

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-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

Exclusion Criteria

Patients:

* With prior ST- elevation myocardial infarction
* Patients presenting \>12hrs
* Not successfully reperfused
* Not completed baseline ECHO evaluation,
* Not accepting participation in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sakarya University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ramazan Akdemir

Prof. Ramazan Akdemir, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ramazan Akdemir, MD

Role: STUDY_CHAIR

Sakarya University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sakarya University, Faculty of Medicine

Sakarya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ramazan Akdemir, MD

Role: CONTACT

[email protected]
00905336020700

Ramazan Akdemir, MD

Role: CONTACT

[email protected]
00905426427388

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ramazan Akdemir, MD

Role: primary

[email protected]
00905336020700

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23969167 (View on PubMed)

Nazer 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.

Reference Type RESULT
PMID: 24297498 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCTSAU1400

Identifier Type: -

Identifier Source: org_study_id