STEMI - ST Elevation Myocardial Infarction Clinical Trial
— NATHANAELOfficial 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
Verified date | April 2024 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 31 |
Est. completion date | June 26, 2021 |
Est. primary completion date | June 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | APHP, Lariboisière Hospital, Cardiology Department | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute coronary resistance | Threshold value correlated with microvascular obstruction on magnetic resonance imaging (MRI) | Immediately after angioplasty | |
Primary | Microvascular obstruction on MRI | Establishment of a correlation between absolute coronary resistance and microvascular obstruction on MRI | Day 7 | |
Secondary | Index of microvascular resistance | Threshold value correlated with microvascular obstruction on MRI | Immediately after angioplasty | |
Secondary | Mean value of absolute coronary resistances corresponding to an IMR > 40 | Establishment of a relationship between absolute coronary resistances and IMR | Immediately after angioplasty | |
Secondary | 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 | Day 7 | |
Secondary | 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 | Immediately after angioplasty | |
Secondary | 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 | Immediately after angioplasty | |
Secondary | Occurrence of early ventricular rhythm disorders | Establishment of a correlation between the absolute coronary resistances and IMR and the early ventricular rhythm disorders | Day 3 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
Recruiting |
NCT04951856 -
Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI
|
Phase 4 | |
Terminated |
NCT04459299 -
CorPath GRX STEMI Study
|
||
Recruiting |
NCT05557019 -
Semi Occlusion of the Coronary Sinus as an Adjunct to PCI in STEMI Patients, FIH Clinical Study
|
N/A | |
Completed |
NCT03527940 -
Prognostic Markers of Patients With STEMI
|
||
Not yet recruiting |
NCT03264859 -
NGAL and Its Association With the No-reflow Phenomenon in ST-elevation Myocardial Infarction
|
N/A | |
Not yet recruiting |
NCT03182855 -
Cangrelor vs. Ticagrelor for Early Platelet Inhibition in STEMI
|
Phase 4 | |
Not yet recruiting |
NCT03266289 -
Evaluation of Short Term Outcome of Different Bifurcation Stenting Techniques at Assuit University Cath. Lab
|
N/A | |
Withdrawn |
NCT04566289 -
Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
|
||
Completed |
NCT04289012 -
HELicobacter Pylori Screening in Patients With Acute Myocardial Infarction Pilot Study
|
N/A | |
Not yet recruiting |
NCT04185077 -
Bivalirudin in Late PCI for Oatients With STEMI
|
Phase 4 | |
Completed |
NCT03609346 -
Asian Registry of the BioFreedom Stent for STEMI Patients
|
||
Recruiting |
NCT05107076 -
Effect of PPCI on Diastolic Function & Levels of Galactin-3 in Patients With STEMI
|
||
Recruiting |
NCT02998853 -
Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure
|
N/A | |
Completed |
NCT03677180 -
National Cardiogenic Shock Initiative
|
||
Completed |
NCT03507777 -
ILUMIEN IV: OPTIMAL PCI
|
N/A | |
Recruiting |
NCT03863327 -
EKG Criteria and Identification of Acute Coronary Occlusion
|
||
Completed |
NCT03070496 -
Multicenter Cohort of STEMI Patients
|
N/A | |
Active, not recruiting |
NCT03874338 -
CLEAR SYNERGY Neutrophil Substudy
|
||
Withdrawn |
NCT05497011 -
A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients
|
N/A |