Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02926755
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2016-08-15
Brief Title:
Multi-modality Imaging in Acute Myocardial Infarction
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Multi-modality Imaging in Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIAMI
Brief Summary:
The goal of this study is to use three 3 different imaging techniquesFractional Flow Reserve FFR allows precise measurement of blood flow in the arteries to the heart and is more reliable than pictures alone to determine the significance of blockages in the heart Near Infra-Red Spectroscopy-Intravascular Ultrasound NIRS IVUS provides information about the amount of lipid and cholesterol in the plaque and plaque volume and Optical Coherence Tomography OCT allows physicians to assess tears in the surface of plaque and plaque thickness to evaluate high risk non-infarct-related coronary lesion in patients who have suffered a recent heart attack underwent successful opening of the artery with a stent and have blockages greater than or equal to 50 in one or more of the other arteries to the heart and to correlate this findings with cardiovascular outcomes at 1 year
Detailed Description:
This is a prospective open-label single center registry The study is designed to characterize plaque ie assess vulnerable plaque features such as plaque tears plaque thickness plaque volume and lipid content in plaque in heart arteries in patients who have suffered a recent acute heart attack and who have blockages 50 in one or more of the other arteries in the heart The procedure to do this will not be the same procedure that was done to open the artery that caused the heart attack but will be scheduled 2-40 days after the first procedure depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure The study will specifically evaluate the plaque characteristics in the arteries that didnt cause the heart attack to see if these arteries have vulnerable plaque and is at risk for future heart attacks If FFR shows abnormal blood flow these arteries will be treated with stents All patients will be followed for 12 months after the second catheterization The purpose of the study is to determine how commonly vulnerable plaques are identified in patients with acute heart attacks and how often these lead to future cardiac problems Identification of plaque features that lead to future problems may allow the development of new medications and devices to prevent future heart attacks and death These same plaque features are also thought to be operative in patients with blockages in the arteries to the brain so this study may have important implications for stroke prevention as well All patients will be considered eligible for participation if they had a recent acute heart attack resulting from complete occlusion of an artery to the heart if the stent procedure to open the artery was successful and if they have blockages 50 in at least one other major heart artery Patients will not be eligible for participation if they are too unstable with regard to heart lung brain or kidney function or if they have previous bypasses to the heart
In selected patients Coronary CT Angiography CCTA will be performed after the initial procedure to open the artery within 40 days CCTA images will be evaluated for plaque characteristics and correlated with the invasive findingsFractional flow reserve via computed tomography FFRCT a non-invasive computed tomography method of measuring blood flow in the blocked arteries will also be determined and correlated with invasive FFR
The standard portion of the procedure includes the angiogram X-ray pictures of the arteries FFR measurement of blood flow in the artery IVUS andor OCT to assess the diameter of the artery and the size of the stent medications and all office visits The research portion of the study requires all imaging studies be performed NIRS IVUS OCT FFR rather than just one or two of these imaging studies and the CCTA
In selected patients Coronary CT Angiography CCTA will be performed after the initial procedure to open the artery within 40 days CCTA images will be evaluated for plaque characteristics and correlated with the invasive findingsFractional flow reserve via computed tomography FFRCT a non-invasive computed tomography method of measuring blood flow in the blocked arteries will also be determined and correlated with invasive FFR
The standard portion of the procedure includes the angiogram X-ray pictures of the arteries FFR measurement of blood flow in the artery IVUS andor OCT to assess the diameter of the artery and the size of the stent medications and all office visits The research portion of the study requires all imaging studies be performed NIRS IVUS OCT FFR rather than just one or two of these imaging studies and the CCTA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None