Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01538303 |
| Other study ID # |
NL-3793806011 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2012 |
| Est. completion date |
October 2012 |
Study information
| Verified date |
February 2023 |
| Source |
Catharina Ziekenhuis Eindhoven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
