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Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction (NATHANAEL)

Primary Purpose

STEMI - ST Elevation Myocardial Infarction

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Absolute coronary flow and resistance measurements

IMR measurement

About this trial

This is an interventional diagnostic trial for STEMI - ST Elevation Myocardial Infarction focused on measuring Coronary physiology, Coronary microvascular circulation, STEMI, Microvascular Obstruction, No Reflow, Rayflow®, Absolute coronary resistance, IMR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Acute ST + coronary syndrome seen within 12 hours after the initial pain: ST offset in 2 contiguous leads ≥ 1mm or ≥ 2mm in precordial or inaugural left branch block, permanent or transient with chest pain > 20 min
Patient with an indication for emergency coronary angiography with angioplasty
Acute occlusion of a large caliber artery corresponding to an APPROACH score ≥21: proximal or mean anterior interventricular artery, proximal circumflex artery or proximal right coronary artery
Final Thrombolysis In Myocardial Infarction (TIMI) of 2 or 3 at the end of the angioplasty procedure regardless of the initial TIMI score
Free and informed written consent to participate in the study

Exclusion Criteria:

Known history of infarction in the same territory : STEMI or NSTEMI (angioplasty programmed for angina does not constitute a criterion for non-inclusion)
Haemodynamic instability requiring the initial use of vasopressive amines or circulatory assistance (counterpulse balloon or extracorporeal membrane oxygenation) or mechanical ventilation (a recovered cardiopulmonary arrest does not constitute an exclusion criterion)
Technical impossibility of performing IMR or Rayflow® measurements (tortuous or calcified artery)
Persistent high-grade atrioventricular block after primary angioplasty
Cardiomyopathy or severe valvulopathy which can induce microcirculatory abnormalities (congenital heart diseases, dilated cardiomyopathy, cardiac amyloidosis, hypertrophic heart disease, mitral regurgitation, aortic regurgitation, tricuspid regurgitation or pulmonary regurgitation grade 3 or 4, tight aortic stenosis or pulmonary stenosis with average gradient > 40 mmHg or vmax > 4m/sec , tight mitral stenosis or tricuspid stenosis with average gradient > 10mmHg)
Contraindication to performing cardiac MRI: wearing a pacemaker, intracerebral clip, intraocular foreign body, neurostimulator, severe renal failure with glomerular filtration rate < 30 mL/min, body weight > 150 kg
Age < 18 years
Pregnant or breastfeeding woman
Inclusion in another research protocol < 30 days
Patient not affiliated to a social security scheme
Patient under guardianship or curatorship

Sites / Locations

APHP, Lariboisière Hospital, Cardiology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Absolute coronary resistances and IMR after angioplasty

Arm Description

Patients with STEMI by acute occlusion of a large caliber coronary artery that had been admitted to hospital less than 12 hours and revascularized by primary angioplasty with good final result.

Outcomes

Primary Outcome Measures

Absolute coronary resistance

Threshold value correlated with microvascular obstruction on magnetic resonance imaging (MRI)

Microvascular obstruction on MRI

Establishment of a correlation between absolute coronary resistance and microvascular obstruction on MRI

Secondary Outcome Measures

Index of microvascular resistance

Threshold value correlated with microvascular obstruction on MRI

Mean value of absolute coronary resistances corresponding to an IMR > 40

Establishment of a relationship between absolute coronary resistances and IMR

Microvascular obstruction in patients with IMR > 40

Establishment of a correlation between an IMR> 40 and the presence and the degree of microvascular obstruction as meaasured by cardiac MRI of the of infarcted area

Absolute coronary resistance indexed to the myocardial mass

Establishment of a correlation between the indexed absolute coronary resistance and the presence and the degree of microvascular obstruction on cardiac MRI

IMR indexed to the myocardial mass

Establishment of a correlation between the indexed IMR and the presence and the degree of microvascular obstruction on cardiac MRI

Occurrence of early ventricular rhythm disorders

Establishment of a correlation between the absolute coronary resistances and IMR and the early ventricular rhythm disorders

Full Information

NCT ID

NCT04542889

First Posted

March 6, 2020

Last Updated

May 30, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04542889

Brief Title

Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction

Acronym

NATHANAEL

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

September 7, 2020 (Actual)

Primary Completion Date

June 26, 2021 (Actual)

Study Completion Date

June 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 IMR>40 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.

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 practices.The 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. Bayer's Medrad® Mark 7 Arterion® infuser will be used to deliver saline continuously at a flow rate of 15-20 mL/min through the Rayflow® microcatheter

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

STEMI - ST Elevation Myocardial Infarction

Keywords

Coronary physiology, Coronary microvascular circulation, STEMI, Microvascular Obstruction, No Reflow, Rayflow®, Absolute coronary resistance, IMR

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Absolute coronary resistances and IMR after angioplasty

Arm Type

Experimental

Arm Description

Patients with STEMI by acute occlusion of a large caliber coronary artery that had been admitted to hospital less than 12 hours and revascularized by primary angioplasty with good final result.

Intervention Type

Diagnostic Test

Intervention Name(s)

Absolute coronary flow and resistance measurements

Intervention Description

Thermodilution-based measurements of absolute coronary resistances using the FFR pressure guide (PressureWire® Certus® from St Jude Medical Abbott) and the Rayflow® microcatheter (Hexacath, Paris, France).

Intervention Type

Diagnostic Test

Intervention Name(s)

IMR measurement

Intervention Description

IMR measurement by thermodilution using the St Jude pressure guide.

Primary Outcome Measure Information:

Title

Absolute coronary resistance

Description

Threshold value correlated with microvascular obstruction on magnetic resonance imaging (MRI)

Time Frame

Immediately after angioplasty

Title

Microvascular obstruction on MRI

Description

Establishment of a correlation between absolute coronary resistance and microvascular obstruction on MRI

Time Frame

Day 7

Secondary Outcome Measure Information:

Title

Index of microvascular resistance

Description

Threshold value correlated with microvascular obstruction on MRI

Time Frame

Immediately after angioplasty

Title

Mean value of absolute coronary resistances corresponding to an IMR > 40

Description

Establishment of a relationship between absolute coronary resistances and IMR

Time Frame

Immediately after angioplasty

Title

Microvascular obstruction in patients with IMR > 40

Description

Establishment of a correlation between an IMR> 40 and the presence and the degree of microvascular obstruction as meaasured by cardiac MRI of the of infarcted area

Time Frame

Day 7

Title

Absolute coronary resistance indexed to the myocardial mass

Description

Establishment of a correlation between the indexed absolute coronary resistance and the presence and the degree of microvascular obstruction on cardiac MRI

Time Frame

Immediately after angioplasty

Title

IMR indexed to the myocardial mass

Description

Establishment of a correlation between the indexed IMR and the presence and the degree of microvascular obstruction on cardiac MRI

Time Frame

Immediately after angioplasty

Title

Occurrence of early ventricular rhythm disorders

Description

Establishment of a correlation between the absolute coronary resistances and IMR and the early ventricular rhythm disorders

Time Frame

Day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Acute ST + coronary syndrome seen within 12 hours after the initial pain: ST offset in 2 contiguous leads ≥ 1mm or ≥ 2mm in precordial or inaugural left branch block, permanent or transient with chest pain > 20 min Patient with an indication for emergency coronary angiography with angioplasty Acute occlusion of a large caliber artery corresponding to an APPROACH score ≥21: proximal or mean anterior interventricular artery, proximal circumflex artery or proximal right coronary artery Final Thrombolysis In Myocardial Infarction (TIMI) of 2 or 3 at the end of the angioplasty procedure regardless of the initial TIMI score Free and informed written consent to participate in the study Exclusion Criteria: Known history of infarction in the same territory : STEMI or NSTEMI (angioplasty programmed for angina does not constitute a criterion for non-inclusion) Haemodynamic instability requiring the initial use of vasopressive amines or circulatory assistance (counterpulse balloon or extracorporeal membrane oxygenation) or mechanical ventilation (a recovered cardiopulmonary arrest does not constitute an exclusion criterion) Technical impossibility of performing IMR or Rayflow® measurements (tortuous or calcified artery) Persistent high-grade atrioventricular block after primary angioplasty Cardiomyopathy or severe valvulopathy which can induce microcirculatory abnormalities (congenital heart diseases, dilated cardiomyopathy, cardiac amyloidosis, hypertrophic heart disease, mitral regurgitation, aortic regurgitation, tricuspid regurgitation or pulmonary regurgitation grade 3 or 4, tight aortic stenosis or pulmonary stenosis with average gradient > 40 mmHg or vmax > 4m/sec , tight mitral stenosis or tricuspid stenosis with average gradient > 10mmHg) Contraindication to performing cardiac MRI: wearing a pacemaker, intracerebral clip, intraocular foreign body, neurostimulator, severe renal failure with glomerular filtration rate < 30 mL/min, body weight > 150 kg Age < 18 years Pregnant or breastfeeding woman Inclusion in another research protocol < 30 days Patient not affiliated to a social security scheme Patient under guardianship or curatorship

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georgios SIDERIS, MD

Organizational Affiliation

APHP, Lariboisière Hospital, Cardiology Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

APHP, Lariboisière Hospital, Cardiology Department

City

Paris

ZIP/Postal Code

75475

Country

France

12. IPD Sharing Statement

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Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction

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