Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04542889
Status:
TERMINATED
Last Update Posted:
2024-05-02
First Post:
2020-03-06
Brief Title:
Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Study of the Coronary Microcirculation After Primary Angioplasty Analysis of Absolute Coronary Blood Flow Rates and Resistance Index of Microcirculatory Resistance and Comparison With Magnetic Resonance Imaging
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Departure of principal investigator
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NATHANAEL
Brief Summary:
In the management of acute myocardial infarction treated with primary angioplasty despite effective epicardial clearance obtained in 95 of cases microvascular obstruction MVO in the damaged territory concerns 50 of patients The Index of Microvascular Resistance IMR allows early assessment of the microcirculatory state during the angioplasty procedure A value of IMR40 indicates MVO and is correlated with morbi-mortality A new method for immediate evaluation of MVO using thermodilution with a new Rayflow microcatheter has been described it no longer allows the estimation but the measurements of absolute coronary resistance and coronary flow We hypothesize that these measurements allows a better evaluation of the microcirculatory state after primary angioplasty comparing to IMR
The main objective is to study the diagnostic performance of Rayflow to predict MVO - no reflow NR - in ST-Elevation Myocardial Infarction STEMI patients in order to determine an absolute coronary resistance threshold by thermodilution for early diagnosis of MVO
The main secondary objectives will be to compare the different microcirculatory assessment parameters with each other not indexed and indexed to the myocardial mass at risk coronary resistance IMR CFR Resistance Reserve Ratio and to establish a link between high resistance or IMR and the occurrence of rhythm disorders at D1 D2 and D3
The main objective is to study the diagnostic performance of Rayflow to predict MVO - no reflow NR - in ST-Elevation Myocardial Infarction STEMI patients in order to determine an absolute coronary resistance threshold by thermodilution for early diagnosis of MVO
The main secondary objectives will be to compare the different microcirculatory assessment parameters with each other not indexed and indexed to the myocardial mass at risk coronary resistance IMR CFR Resistance Reserve Ratio and to establish a link between high resistance or IMR and the occurrence of rhythm disorders at D1 D2 and D3
Detailed Description:
All patients presenting for STEMI by occlusion of a proximal coronary artery vascularizing a large volume of myocardium corresponding to an APPROACH score 21 in the first 12 hours following the onset of chest pain will be included
Data relating to medical history lifestyle sedentary lifestyle smoking drug use cardiovascular risk factors will be collected
The management of acute coronary syndrome will be carried out in accordance with the European Society of Cardiology guidelines of 2015 An emergency coronary angiography will be used to revascularise the patient as indicated Thromboaspiration stenting antithrombotic agents and other treatments will be administered according to angiographic and clinical criteria
The FFR guide PressureWire Certus from St Jude Medical Abbott will be used to make pressure and temperature measurements It has been used in daily practice since the FAME study in 2011 to guide the therapeutic decision in patients with an intermediate lesion
An injected cardiac magnetic resonance imaging MRI will be performed between 48 hours and 7 days following the infarction in accordance with current practicesThe initial trans-thoracic ultrasonography as well as the various blood samplings will be performed according to standard practice
The Rayflow microcatheter will be used to allow the optimal delivery of physiological saline solution into the studied artery It will be mounted on the FFR guide already in place as part of the angioplasty procedure Bayers Medrad Mark 7 Arterion infuser will be used to deliver saline continuously at a flow rate of 15-20 mLmin through the Rayflow microcatheter
Data relating to medical history lifestyle sedentary lifestyle smoking drug use cardiovascular risk factors will be collected
The management of acute coronary syndrome will be carried out in accordance with the European Society of Cardiology guidelines of 2015 An emergency coronary angiography will be used to revascularise the patient as indicated Thromboaspiration stenting antithrombotic agents and other treatments will be administered according to angiographic and clinical criteria
The FFR guide PressureWire Certus from St Jude Medical Abbott will be used to make pressure and temperature measurements It has been used in daily practice since the FAME study in 2011 to guide the therapeutic decision in patients with an intermediate lesion
An injected cardiac magnetic resonance imaging MRI will be performed between 48 hours and 7 days following the infarction in accordance with current practicesThe initial trans-thoracic ultrasonography as well as the various blood samplings will be performed according to standard practice
The Rayflow microcatheter will be used to allow the optimal delivery of physiological saline solution into the studied artery It will be mounted on the FFR guide already in place as part of the angioplasty procedure Bayers Medrad Mark 7 Arterion infuser will be used to deliver saline continuously at a flow rate of 15-20 mLmin through the Rayflow microcatheter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02413-54 | OTHER | IDRCB | None |