STEMI - ST Elevation Myocardial InfarctionNATHANAELNCT04542889
Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction
A study testing Absolute coronary flow and resistance measurements and IMR measurement in people with STEMI - ST Elevation Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Absolute coronary flow and resistance measurements and IMR measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2020to 26 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patient not affiliated to a social security scheme
- Patient under guardianship or curatorship
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Absolute coronary flow and resistance measurements, IMR measurement
- Keywords
- Coronary physiology, Coronary microvascular circulation, STEMI, Microvascular Obstruction, No Reflow, Rayflow®, Absolute coronary resistance, IMR
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absolute coronary flow and resistance measurementsDiagnostic test
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).
IMR measurementDiagnostic test
IMR measurement by thermodilution using the St Jude pressure guide.
| Study group | Role | What they receive |
|---|---|---|
| Absolute coronary resistances and IMR after angioplasty | Experimental | 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. Receives: Diagnostic Test: Absolute coronary flow and resistance measurements; Diagnostic Test: IMR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute coronary resistance
Threshold value correlated with microvascular obstruction on magnetic resonance imaging (MRI)
Measured: Immediately after angioplasty
Microvascular obstruction on MRI
Establishment of a correlation between absolute coronary resistance and microvascular obstruction on MRI
Measured: Day 7
Secondary outcomes (6)
Index of microvascular resistance
Threshold value correlated with microvascular obstruction on MRI
Measured: Immediately after angioplasty
Mean value of absolute coronary resistances corresponding to an IMR > 40
Establishment of a relationship between absolute coronary resistances and IMR
Measured: Immediately after angioplasty
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
Measured: Day 7
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
Measured: Immediately after angioplasty
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
Measured: Immediately after angioplasty
Occurrence of early ventricular rhythm disorders
Establishment of a correlation between the absolute coronary resistances and IMR and the early ventricular rhythm disorders
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start7 Sep 2020
- Primary completion26 Jun 2021
- Study completion26 Jun 2021
Why it stopped: Departure of principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgios SIDERIS, MD, Principal investigator, APHP, Lariboisière Hospital, Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542889
- Sponsor's protocol ID
- APHP190831
- Other IDs
- 2019-A02413-54
- Acronym
- NATHANAEL
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2020
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04542889
- Acronym / sponsor ID
- NATHANAEL / APHP190831
- Keywords
- Coronary physiology, Coronary microvascular circulation, STEMI, Microvascular Obstruction, No Reflow, Rayflow®, Absolute coronary resistance, IMR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of principal investigator
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 26 Jun 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Absolute coronary resistances and IMR after angioplasty | Experimental | Diagnostic Test: Absolute coronary flow and resistance measurements, Diagnostic Test: IMR measurementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absolute coronary flow and resistance measurementsThermodilution-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). | Diagnostic test | Absolute coronary resistances and IMR after angioplasty |
| IMR measurementIMR measurement by thermodilution using the St Jude pressure guide. | Diagnostic test | Absolute coronary resistances and IMR after angioplasty |
Primary outcome
Absolute coronary resistance
Time frame: Immediately after angioplasty
Threshold value correlated with microvascular obstruction on magnetic resonance imaging (MRI)
Microvascular obstruction on MRI
Time frame: Day 7
Establishment of a correlation between absolute coronary resistance and microvascular obstruction on MRI
6 secondary outcomes
Index of microvascular resistance
Time frame: Immediately after angioplasty
Mean value of absolute coronary resistances corresponding to an IMR > 40
Time frame: Immediately after angioplasty
Microvascular obstruction in patients with IMR > 40
Time frame: Day 7
Absolute coronary resistance indexed to the myocardial mass
Time frame: Immediately after angioplasty
IMR indexed to the myocardial mass
Time frame: Immediately after angioplasty
Occurrence of early ventricular rhythm disorders
Time frame: Day 3
Results and safety
The study was stopped early (reason given: Departure of principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios SIDERIS, MD principal investigator
APHP, Lariboisière Hospital, Cardiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absolute coronary flow and resistance measurements and IMR measurement in people with STEMI - ST Elevation Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Departure of principal investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute coronary resistance (time frame: Immediately after angioplasty). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.