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NCT01869998 Clinical Trial

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

Acute Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01869998
Other study ID # 4-2012-0040
Secondary ID
Status Recruiting
Phase N/A
First received May 30, 2013
Last updated February 4, 2014
Start date February 2012
Est. completion date March 2015

Study information
Verified date February 2014
Source Yonsei University
Contact Geu-Ru Hong, MD
Phone 82-11-502-2076
Email grhong@yuhs.ac
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical 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

Recruitment information / eligibility
Status Recruiting
Enrollment 85
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 90 Years
Eligibility Inclusion Criteria:

1. Patient is = 30 years old

2. Acute anterior wall myocardial infarction showing akinetic or dyskinetic apical wall motion abnormalities on an initial transthoracic echocardiogram

3. Left ventricular ejection fraction less than 40%

Exclusion Criteria:

1. Prior history of myocardial infarction

2. Chronic medication with Coumadin

3. Contraindication of contrast echocardiography

4. Significant atrial or ventricular arrhythmia

5. Valvular heart disease more than moderate degree

6. Decompensated heart failure

7. Very poor echo window, which cannot evaluate the presence of apical thrombus

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Severance cardiovascular hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. Epub 2012 Aug 7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 30 days after initial echocardiography No
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