STEMINCT03439150
Resistance STEMI Study
A study testing Absolute flow and resistance measurement in people with STEMI and Acute Myocardial Infarction, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
In acute myocardial infarction, early restoration of blood flow to the jeopardized myocardium is of paramount importance to limit infarct size and to improve long term outcome. Primary percutaneous coronary intervention (PPCI) is the treatment of choice in these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- STEMI, Acute Myocardial Infarction
- What is being tested?
- Absolute flow and resistance measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Oct 2018to 1 Jul 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Presentation within 12 hours after the onset of complaints
- Acute ST-elevation myocardial infarction with a total ST segment deviation ≥5 mm
- Able to give and understand informed consent
- Culprit lesion in a proximal or mid-segment of one of the major coronary arteries (diameter ≥2,5 mm), which is stented successfully
- Stable condition after stenting
- One or more additional lesions in one or more different coronary arteries, mandating FFR measurement +/- PPCI during the subacute phase
Who cannot join
- Age < 18 years or > 75 years
- Cardiogenic shock or pre-shock, determined by the clinician
- Patients with previous myocardial infarction in the culprit artery or with previous bypass surgery
- Very tortuous or calcified coronary arteries
- Long or complex PPCI
- Severe concomitant disease or conditions with a life expectancy of less than 1 year
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- Inability to understand and give informed consent
- Known myocardial diseases such as severe left ventricular hypertrophy or cardiomyopathy
- Pregnancy
- Severe conduction disturbances necessitating implantation of a temporary pacemaker
- Contraindications for MRI (claustrophobia, ferromagnetic metal fragments in the body)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery of Microvascular Myocardial Resistance After ST Elevation Myocardial Infarction and Its Relation to Outcome. A Prospective Exploratory Study
In acute myocardial infarction, early restoration of blood flow to the jeopardized myocardium is of paramount importance to limit infarct size and to improve long term outcome. Primary percutaneous coronary intervention (PPCI) is the treatment of choice in these patients. Despite achievement of adequate epicardial coronary artery reperfusion in many patients, transient or persistent myocardial microvascular dysfunction is often present, also referred to as the no-reflow phenomenon. This microvascular dysfunction and the time course during which it recovers, is most likely also related to long term outcome.
If microvascular reperfusion is still limited immediately after myocardial infarction but recovers quickly in the days thereafter, this might be beneficial for long term prognosis.
Read more
Several treatments have been suggested to limit microvascular injury and to improve microvascular reperfusion in the acute phase of myocardial infarction (such as intra-aortic balloon pumping, glycoprotein IIB/IIIA inhibitors, adenosine, verapamil, nitroglycerine, cyclosporine, or gap-junction-inhibitors), but it has been difficult to assess the effect of such treatment due to the simple fact that no methodology has been available for quantitative assessment of the microcirculation of the heart.
Assessment of microvascular perfusion and function has been very difficult so far and has been hampered by a number of methodological and technical shortcomings. Measurement of absolute blood flow in the infarcted area and true quantitative calculation of absolute resistance in acute myocardial infarction, has been introduced in the last years using a technique with thermodilution and continuous infusion of small amounts of saline. This technique offers the possibility to study the course of microvascular (dys)function after acute myocardial infarction with potentially important implications for treatment at follow-up. Technical performance of such measurements was difficult so far because of a complex instrumentation and the necessity of additional administration of intravenous adenosine. In the last 2 years, this technique has been largely simplified by the introduction of a new multipurpose monorail infusion catheter (RayFlow ®, Hexacath, Paris) and the observation that saline infusion of 15-20 ml/min in itself already ensures maximum coronary hyperemia. Finally, easy to handle software has been developed for online interpretation of such measurements. Consequently, measurement of absolute blood flow and myocardial resistance has become easy to perform now and the complete measurements only take a few minutes in addition to a regular PPCI or Fractional Flow Reserve (FFR) measurement. The measurements are absolutely safe, reproducible, only a small amount of saline (100 ml at room temperature) is needed, no additional medication is necessary, the patient doesn't experience any discomfort of the measurement and the measurements can be repeated multiple times within minutes.
Therefore, a window is opened for further examination and quantitative assessment of the microcirculation of the heart. The purpose of the present study is to evaluate changes in myocardial resistance over time in ST-Elevation Myocardial Infarction (STEMI) patients, both in the early stage and the subacute phase. Furthermore, the course of such changes and recovery of the microcirculation will be correlated to long-term outcome as assessed by Magnetic Resonance Imaging (MRI) measurements and final infarct size. It is hypothesized that patients can be divided into 3 groups:
- Patients with an (almost) normal resistance and flow immediately after PPCI B. Patients with still elevated resistance and decreased flow immediately after PPCI, but (partial) recovery in the next days C. Patients with elevated resistance and decreased flow immediately after PPCI which do not recover at all.
The investigators would like to evaluate changes in microvascular resistance of the infarcted area in the first hour after ST-elevation myocardial infarction and during the recovery period (<5 days). Classify patients according to recovery of microvascular resistance and relate the (recovery of) microvascular resistance to outcome and preservation of left ventricular function (with MRI, echo and clinical follow-up at 1 year).
- Conditions
- STEMI, Acute Myocardial Infarction
- Being tested
- Absolute flow and resistance measurement
- Keywords
- Absolute flow measurement, Microvascular resistance, Left ventricular function
- 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 flow and resistance measurementDiagnostic test
Absolute flow and resistance measurements immediately after PPCI of the culprit vessel (in a STEMI setting) and repeated absolute flow and resistance measurements after 3-7 days
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Other | The study arm will undergo absolute flow and resistance measurements immediately after PPCI of the culprit artery Receives: Diagnostic Test: Absolute flow and resistance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint - changes in microvascular resistance
To evaluate changes in microvascular resistance of the infarcted area in the first hour after ST-elevation myocardial infarction and during the recovery period (<5 days) measured invasively with the absolute flow and resistance measurement.
Measured: From date of randomization until the date of the second measurements (all within the first week after the index event).
Co-primary endpoint - risk stratification
The co-primary endpoint is to see whether the microvascular resistance can classify the patients into groups and identify those with a higher risk of reduced left ventricular function and more adverse events in the end.
Measured: From date of randomization until the date of clinical follow-up at 1 year.
Secondary outcomes (2)
Secondary endpoint - left ventricular function
To relate (recovery of) microvascular resistance to the preservation of left ventricular function (assessed by MRI and echocardiography).
Measured: From date of randomization until the date of clinical follow-up at 1 year.
Secondary outcome- Major adverse events
To relate (recovery of) microvascular resistance to the outcome (adverse events / mortality) during to complete clinical follow up of the patient at 3 months and 1 year
Measured: From date of randomization until the date of clinical follow-up at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start15 Oct 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Why it stopped: slow enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nico Pijls, Catharina Ziekenhuis Eindhoven
- Investigators
- Nico Pijls, MD, PhD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439150
- Sponsor's protocol ID
- Resistance STEMI
- Status last verified
- Jul 2020
- First submitted
- 2 Feb 2018
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Microvascular Myocardial Resistance After ST Elevation Myocardial Infarction and Its Relation to Outcome. A Prospective Exploratory Study
- ClinicalTrials.gov ID
- NCT03439150
- Acronym / sponsor ID
- Resistance STEMI
- Conditions
- STEMI, Acute Myocardial Infarction
- Keywords
- Absolute flow measurement, Microvascular resistance, Left ventricular function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrolment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 20 Feb 2018 (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 acute myocardial infarction, early restoration of blood flow to the jeopardized myocardium is of paramount importance to limit infarct size and to improve long term outcome. Primary percutaneous coronary intervention (PPCI) is the treatment of choice in these patients. Despite achievement of adequate epicardial coronary artery reperfusion in many patients, transient or persistent myocardial microvascular dysfunction is often present, also referred to as the no-reflow phenomenon. This microvascular dysfunction and the time course during which it recovers, is most likely also related to long term outcome.
If microvascular reperfusion is still limited immediately after myocardial infarction but recovers quickly in the days thereafter, this might be beneficial for long term prognosis.
Several treatments have been suggested to limit microvascular injury and to improve microvascular reperfusion in the acute phase of myocardial infarction (such as intra-aortic balloon pumping, glycoprotein IIB/IIIA inhibitors, adenosine, verapamil, nitroglycerine, cyclosporine, or gap-junction-inhibitors), but it has been difficult to assess the effect of such treatment due to the simple fact that no methodology has been available for quantitative assessment of the microcirculation of the heart.
Assessment of microvascular perfusion and function has been very difficult so far and has been hampered by a number of methodological and technical shortcomings. Measurement of absolute blood flow in the infarcted area and true quantitative calculation of absolute resistance in acute myocardial infarction, has been introduced in the last years using a technique with thermodilution and continuous infusion of small amounts of saline. This technique offers the possibility to study the course of microvascular (dys)function after acute myocardial infarction with potentially important implications for treatment at follow-up. Technical performance of such measurements was difficult so far because of a complex instrumentation and the necessity of additional administration of intravenous adenosine. In the last 2 years, this technique has been largely simplified by the introduction of a new multipurpose monorail infusion catheter (RayFlow ®, Hexacath, Paris) and the observation that saline infusion of 15-20 ml/min in itself already ensures maximum coronary hyperemia. Finally, easy to handle software has been developed for online interpretation of such measurements. Consequently, measurement of absolute blood flow and myocardial resistance has become easy to perform now and the complete measurements only take a few minutes in addition to a regular PPCI or Fractional Flow Reserve (FFR) measurement. The measurements are absolutely safe, reproducible, only a small amount of saline (100 ml at room temperature) is needed, no additional medication is necessary, the patient doesn't experience any discomfort of the measurement and the measurements can be repeated multiple times within minutes.
Therefore, a window is opened for further examination and quantitative assessment of the microcirculation of the heart. The purpose of the present study is to evaluate changes in myocardial resistance over time in ST-Elevation Myocardial Infarction (STEMI) patients, both in the early stage and the subacute phase. Furthermore, the course of such changes and recovery of the microcirculation will be correlated to long-term outcome as assessed by Magnetic Resonance Imaging (MRI) measurements and final infarct size. It is hypothesized that patients can be divided into 3 groups:
- Patients with an (almost) normal resistance and flow immediately after PPCI B. Patients with still elevated resistance and decreased flow immediately after PPCI, but (partial) recovery in the next days C. Patients with elevated resistance and decreased flow immediately after PPCI which do not recover at all.
The investigators would like to evaluate changes in microvascular resistance of the infarcted area in the first hour after ST-elevation myocardial infarction and during the recovery period (<5 days). Classify patients according to recovery of microvascular resistance and relate the (recovery of) microvascular resistance to outcome and preservation of left ventricular function (with MRI, echo and clinical follow-up at 1 year).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Other | Diagnostic Test: Absolute flow and resistance measurementThe study arm will undergo absolute flow and resistance measurements immediately after PPCI of the culprit artery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years
- Presentation within 12 hours after the onset of complaints
- Acute ST-elevation myocardial infarction with a total ST segment deviation ≥5 mm
- Able to give and understand informed consent
- Culprit lesion in a proximal or mid-segment of one of the major coronary arteries (diameter ≥2,5 mm), which is stented successfully
Key exclusion criteria (11 listed)
- Age < 18 years or > 75 years
- Cardiogenic shock or pre-shock, determined by the clinician
- Patients with previous myocardial infarction in the culprit artery or with previous bypass surgery
- Very tortuous or calcified coronary arteries
- Long or complex PPCI
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 flow and resistance measurementAbsolute flow and resistance measurements immediately after PPCI of the culprit vessel (in a STEMI setting) and repeated absolute flow and resistance measurements after 3-7 days | Diagnostic test | Study arm |
Primary outcome
Primary endpoint - changes in microvascular resistance
Time frame: From date of randomization until the date of the second measurements (all within the first week after the index event).
To evaluate changes in microvascular resistance of the infarcted area in the first hour after ST-elevation myocardial infarction and during the recovery period (<5 days) measured invasively with the absolute flow and resistance measurement.
Co-primary endpoint - risk stratification
Time frame: From date of randomization until the date of clinical follow-up at 1 year.
The co-primary endpoint is to see whether the microvascular resistance can classify the patients into groups and identify those with a higher risk of reduced left ventricular function and more adverse events in the end.
2 secondary outcomes
Secondary endpoint - left ventricular function
Time frame: From date of randomization until the date of clinical follow-up at 1 year.
Secondary outcome- Major adverse events
Time frame: From date of randomization until the date of clinical follow-up at 1 year.
Results and safety
The study was stopped early (reason given: slow enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
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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.
Nico Pijls, MD, PhD principal investigator
Catharina Ziekenhuis Eindhoven
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 flow and resistance measurement in people with STEMI and Acute Myocardial Infarction, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 11 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 16 Jul 2020. 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 Netherlands. 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: slow enrolment). 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?
Primary endpoint - changes in microvascular resistance (time frame: From date of randomization until the date of the second measurements (all within the first week after the index event).). 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 16 Jul 2020.