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
• 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

• Acute Myocardial Infarction
• Apical Thrombus Formation
• Infarction
• Myocardial Infarction

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