Apical Thrombus FormationNCT01869998
Implication of Left veNtricle Vortex Flow Guided aNticOagulation Therapy for preVenting Apical Thrombus Formation In Patients With Acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION Study
An observational study of Apical Thrombus Formation and Acute Myocardial Infarction, run by Yonsei University at 1 site in South Korea.
Trial summary
Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION study Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Apical Thrombus Formation, Acute Myocardial Infarction
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Sep 2015
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute anterior wall myocardial infarction showing akinetic or dyskinetic apical wall motion abnormalities on an initial transthoracic echocardiogram
Who may be able to join
- Patient is ≥ 30 years old
- Acute anterior wall myocardial infarction showing akinetic or dyskinetic apical wall motion abnormalities on an initial transthoracic echocardiogram
- Left ventricular ejection fraction less than 40%
Who cannot join
- Prior history of myocardial infarction
- Chronic medication with Coumadin
- Contraindication of contrast echocardiography
- Significant atrial or ventricular arrhythmia
- Valvular heart disease more than moderate degree
- Decompensated heart failure
- Very poor echo window, which cannot evaluate the presence of apical thrombus
Trial locations and contacts
1 site in 1 country.
About this study
Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION study
- Keywords
- Vortex, Thrombus, Contrast echocardiography, Prediction and prevention of apical thrombus formation in acute myocardial infarction patient by using Vortex parameters.
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low risk group (A) | (A)Vortex depth≥0.45 | |
| High risk group 1 (B) | (B)Vortex depth<0.45 with anticoagulation | |
| High risk group 2 (C) | (C)Vortex depth <0.45 without anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical thrombus formation in echocardiography
Evaluate and compare the incidence of thrombus formation in high risk group (Vortex depth < 0.45) and low risk group (Vortex Depth ≥ 0.45)
Measured: 30 days after initial echocardiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apical Thrombus FormationStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869998
- Sponsor's protocol ID
- 4-2012-0040
- Status last verified
- May 2016
- First submitted
- 30 May 2013
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Son JW, Park WJ, Choi JH, Houle H, Vannan MA, Hong GR, Chung N. Abnormal left ventricular vortex flow patterns in association with left ventricular apical thrombus formation in patients with anterior myocardial infarction: a quantitative analysis by contrast echocardiography. Circ J. 2012;76(11):2640-6. doi: 10.1253/circj.cj-12-0360. Epub 2012 Aug 7.
PubMed 22878352
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Left veNtricle Vortex Flow Guided aNticOagulation Therapy for preVenting Apical Thrombus Formation In Patients With Acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION Study
- ClinicalTrials.gov ID
- NCT01869998
- Acronym / sponsor ID
- 4-2012-0040
- Keywords
- Vortex, Thrombus, Contrast echocardiography, Prediction and prevention of apical thrombus formation in acute myocardial infarction patient by using Vortex parameters.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Jun 2013 (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.
Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION study
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low risk group (A) | – | –(A)Vortex depth≥0.45 |
| High risk group 1 (B) | – | –(B)Vortex depth<0.45 with anticoagulation |
| High risk group 2 (C) | – | –(C)Vortex depth <0.45 without anticoagulation |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute anterior wall myocardial infarction showing akinetic or dyskinetic apical wall motion abnormalities on an initial transthoracic echocardiogram
Key inclusion criteria (3 listed)
- Patient is ≥ 30 years old
- Acute anterior wall myocardial infarction showing akinetic or dyskinetic apical wall motion abnormalities on an initial transthoracic echocardiogram
- Left ventricular ejection fraction less than 40%
Key exclusion criteria (7 listed)
- Prior history of myocardial infarction
- Chronic medication with Coumadin
- Contraindication of contrast echocardiography
- Significant atrial or ventricular arrhythmia
- Valvular heart disease more than moderate degree
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apical thrombus formation in echocardiography
Time frame: 30 days after initial echocardiography
Evaluate and compare the incidence of thrombus formation in high risk group (Vortex depth < 0.45) and low risk group (Vortex Depth ≥ 0.45)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Background: PubMed 22878352Son JW, Park WJ, Choi JH, Houle H, Vannan MA, Hong GR, Chung N. Abnormal left ventricular vortex flow patterns in association with left ventricular apical thrombus formation in patients with anterior myocardial infarction: a quantitative analysis by contrast echocardiography. Circ J. 2012;76(11):2640-6. doi: 10.1253/circj.cj-12-0360. Epub 2012 Aug 7.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Thrombus Formation and Acute Myocardial Infarction, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 10 May 2016. 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 South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apical thrombus formation in echocardiography (time frame: 30 days after initial echocardiography). 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 NCT01869998, which also lists 1 linked publication.
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 10 May 2016.