ST Segment Elevation Myocardial InfarctionNCT01538303
Microvascular Dysfunction in Acute Myocardial Infarction (AMI) and Its Relation to Outcome
An observational study of ST Segment Elevation Myocardial Infarction, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
The purpose of this study is first to evaluate absolute myocardial blood flow and resistance over time in the acute and sub-acute phase of myocardial infarction and second, to correlate these parameters to preservation of left ventricular function and long-term outcome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Oct 2012
- Phase
- Observational
- 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
Study population: The study population consists of patients with STEMI either in our own hospital either referred by other hospitals or the ambulance.
Who may be able to join
- STEMI < 12 hours
- > 10mm ST-segment deviation
- culprit lesion in proximal or mid segment of a coronary artery with a reference diameter > 3.0mm by visual estimation.
- hemodynamically stable.
Who cannot join
- Age > 75 years
- cardiogenic shock or pre-shock
- Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic.
- Patients with previous myocardial infarction in the culprit area of with previous bypass surgery
- Tortuous coronary arteries or complex or long-lasting primary PCI
- Severe concomitant disease or conditions with a life expectancy of less than one year
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- Inability to understand and give informed consent either in first instance on the table or in second instance on the coronary care unit.
- Other known myocardial diseases, such as moderate or severe left ventricular hypertrophy or cardiomyopathy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5623EJ
About this study
Official title: Microvascular Dysfunction in AMI and Its Relation to Outcome
The purpose of this study is first to evaluate absolute myocardial blood flow and resistance over time in the acute and sub-acute phase of myocardial infarction and second, to correlate these parameters to preservation of left ventricular function and long-term outcome.
Read the detailed description
In acute myocardial infarction, early restoration of epicardial and myocardial blood flow is of paramount importance to limit infarct size and create optimum conditions for favorable long-term outcome.
Presently, restoration of epicardial blood flow is preferably obtained by primary percutaneous coronary intervention (PPCI). PPCI is the treatment of choice for patients with acute myocardial infarction who can be admitted sufficiently fast to a hospital equipped for this type for treatment.
Successful restoration of epicardial blood flow by PPCI is possible in approximately 90% of all patients. Nevertheless, in a number of these patients myocardial hypoperfusion persists due to moderate or severe microvascular dysfunction.
The terminology "no reflow" is often used for this condition. Microvascular thromboembolism, spasm, or intramyocardial oedema are suggested to be responsible for this condition and probably all of these three phenomena play a role. Besides that, inflammatory response of the myocardium can be involved with neutrophil plugging of the capillaries, further compromising restoration of normal myocardial blood flow and function.
It is well known that in patients in whom myocardial reperfusion is absent or limited, despite adequate epicardial reperfusion, prognosis is poor and more severe left ventricular dysfunction can be expected in comparison to those patients in whom also microvascular reperfusion after PPCI is restored. Therefore, it is beyond doubt that knowledge about the actual state of the microvasculature and myocardial (re)perfusion shortly after PPCI, is important from a prognostic point of view.
Moreover, if microvascular reperfusion is still limited immediately after myocardial infarction, but recovers quickly in the days thereafter, this might have important implications for long-term prognosis.
Lastly, knowledge about microvascular reperfusion in the acute phase can be important with respect to choice of adjunct mechanical or medical therapy, such as intra aortic balloon pumping (IABP), Gp IIb/IIIa inhibitors or continuation of nitroglycerine.
Despite this undisputed importance of microvascular perfusion and function in the acute phase of myocardial infarction, its assessment has been difficult so far and has been hampered by a number of methodological and technical shortcomings.It should be realized in this context that the function of the microvasculature in general (and specifically in acute myocardial infarction) can be characterized by myocardial blood flow and resistance.
Recently, the investigators have developed a new technique for measuring absolute coronary and myocardial blood flow and absolute and relative coronary and myocardial resistance This has paved the way to study microvascular function in acute myocardial infarction immediately after epicardial reperfusion by PPCI and in the days thereafter.
- Keywords
- STEMI, absolute flow, microvascular resistance
- 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.
| Study group | Role | What they receive |
|---|---|---|
| measurement absolute flow and resistance | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Segment Elevation Myocardial InfarctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inge Wijnbergen, Catharina Ziekenhuis Eindhoven
- Investigators
- Nico Pijls, MD, PhD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538303
- Sponsor's protocol ID
- NL-3793806011
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2012
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Dysfunction in AMI and Its Relation to Outcome
- ClinicalTrials.gov ID
- NCT01538303
- Acronym / sponsor ID
- NL-3793806011
- Keywords
- STEMI, absolute flow, microvascular resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Feb 2012 (estimated)
- 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.
The purpose of this study is first to evaluate absolute myocardial blood flow and resistance over time in the acute and sub-acute phase of myocardial infarction and second, to correlate these parameters to preservation of left ventricular function and long-term outcome.
Detailed description
In acute myocardial infarction, early restoration of epicardial and myocardial blood flow is of paramount importance to limit infarct size and create optimum conditions for favorable long-term outcome.
Presently, restoration of epicardial blood flow is preferably obtained by primary percutaneous coronary intervention (PPCI). PPCI is the treatment of choice for patients with acute myocardial infarction who can be admitted sufficiently fast to a hospital equipped for this type for treatment.
Successful restoration of epicardial blood flow by PPCI is possible in approximately 90% of all patients. Nevertheless, in a number of these patients myocardial hypoperfusion persists due to moderate or severe microvascular dysfunction.
The terminology "no reflow" is often used for this condition. Microvascular thromboembolism, spasm, or intramyocardial oedema are suggested to be responsible for this condition and probably all of these three phenomena play a role. Besides that, inflammatory response of the myocardium can be involved with neutrophil plugging of the capillaries, further compromising restoration of normal myocardial blood flow and function.
It is well known that in patients in whom myocardial reperfusion is absent or limited, despite adequate epicardial reperfusion, prognosis is poor and more severe left ventricular dysfunction can be expected in comparison to those patients in whom also microvascular reperfusion after PPCI is restored. Therefore, it is beyond doubt that knowledge about the actual state of the microvasculature and myocardial (re)perfusion shortly after PPCI, is important from a prognostic point of view.
Moreover, if microvascular reperfusion is still limited immediately after myocardial infarction, but recovers quickly in the days thereafter, this might have important implications for long-term prognosis.
Lastly, knowledge about microvascular reperfusion in the acute phase can be important with respect to choice of adjunct mechanical or medical therapy, such as intra aortic balloon pumping (IABP), Gp IIb/IIIa inhibitors or continuation of nitroglycerine.
Despite this undisputed importance of microvascular perfusion and function in the acute phase of myocardial infarction, its assessment has been difficult so far and has been hampered by a number of methodological and technical shortcomings.It should be realized in this context that the function of the microvasculature in general (and specifically in acute myocardial infarction) can be characterized by myocardial blood flow and resistance.
Recently, the investigators have developed a new technique for measuring absolute coronary and myocardial blood flow and absolute and relative coronary and myocardial resistance This has paved the way to study microvascular function in acute myocardial infarction immediately after epicardial reperfusion by PPCI and in the days thereafter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measurement absolute flow and resistance | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with STEMI either in our own hospital either referred by other hospitals or the ambulance.
Key inclusion criteria (4 listed)
- STEMI < 12 hours
- > 10mm ST-segment deviation
- culprit lesion in proximal or mid segment of a coronary artery with a reference diameter > 3.0mm by visual estimation.
- hemodynamically stable.
Key exclusion criteria (9 listed)
- Age > 75 years
- cardiogenic shock or pre-shock
- Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic.
- Patients with previous myocardial infarction in the culprit area of with previous bypass surgery
- Tortuous coronary arteries or complex or long-lasting primary PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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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?
An observational study of ST Segment Elevation 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 10 Feb 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 10 Feb 2023.