the aim of this study is to compare the impact of an early-CR within 48 hrs. after PPCI to a late complete revascularization >2 weeks after PPCI on LV remodelling in patients with STEMI and multi-vessel disease.
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
hartinfarct, herstel na behandeling van linker kamer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of our study is to assess the association of timing of CR and
left ventricular remodelling (increase in end diastolic volume [EDV]>20%) or an
increase of at least 5% in left ventricular function after primary PCI in STEMI
patients with multi-vessel disease.
Secondary outcome
The secondary objective of our study is to assess the correlation of plasma
serum BNP level within the first 24-96 hours of STEMI and the development of
subsequent left ventricular dilatation according to CR-group at 3, 6 and 12
months of follow-up on imaging (serial MRI and/or echocardiography) and
mortality (all cause and cardiac).
Background summary
ST-elevation myocardial infarction (STEMI) is a common and the most severe
presentation of ischemic coronary disease. Evidence shows a high risk for
mortality and future events in patients with multivessel disease. Based on a
large retrospective trial, ESC and ACC/AHA guidelines recommend treatment of
culprit lesion only during primary PCI (PPCI). The recent randomized PRAMI
study showed a lower MACCE-rate with preventive complete revascularization of
non-infarct related arteries (Non-IRA) lesions at PPCI. A reduced global
ventricular flow after acute myocardial infarction in non-RA has been suggested
to increase the area at risk with poorer left ventricular remodelling in
previous research (Gibson et al.). However, the mechanism through which MVD
adversely affects outcome is still poorly defined and optimal timing of
complete revascularization remains unclear.
Study objective
the aim of this study is to compare the impact of an early-CR within 48 hrs.
after PPCI to a late complete revascularization >2 weeks after PPCI on LV
remodelling in patients with STEMI and multi-vessel disease.
Study design
prospective study, with sequential allocation
Intervention
After informed consent and immediately after the PPCI patients with multivessel
disease will be randomized to either early complete revascularization (CR <48
hr) after PPCI or CR *2 week after PPCI. A FFR will be gauged of all non-IRA
lesions to judge functional significance and according to randomization all
lesions with a FFR <0.80 will be treated in the same session or in a staged
procedure *2 weeks - 4 weeks after PPCI. From patients enrolled in the trial
blood will be drawn for the additional assessment of plasma BNP, white blood
cell count and HbA1C. Further an echocardiogram and a cardiac MRI (CMR) with
delayed enhancement, requiring the infusion of gadolinium, will be acquired
within 1-3 days after the PPCI.
Study burden and risks
A short (oral) informed consent will be taken to minimize a delay in the
door-to-balloon- time. The usual risks associated with a coronary intervention
are also applicable to our study; in <1% of cases death, stroke, ventricular
fibrillation, myocardial infarction or aortic dissection may occur. These
complications may require a coronary artery bypass surgery. Some bleeding from
the insertion point in the groin (femoral artery) is common, but occasionally a
hematoma may form. Rarely infection at the puncture site, dissection of the
access blood vessel or kidney failure requiring dialysis may occur. Further an
allergic reaction to the contrast dye used is possible, but has been reduced
with newer agents. During primary PCI patients who are randomized to an
immediate complete revascularization will have a longer procedure and possibly
more contrast for the additional treatment of all significant non-IRA lesions
during PPCI. This may result in deterioration of the kidney function or
above-mentioned procedural complications in a non-IRA. Most of these
complications may also occur in an additional procedure. The risk of a complete
revascularization is counterbalanced by the fact that a second procedure, which
may require re-hospitalization, for significant non-IRA lesions is avoided.
Drug eluting stents (DES) will primarily be used for the treatment of non-IRA
lesions and this might require the use of anti-thrombotic therapy for a longer
duration. However the final decision for a DES or bare metal stent (BMS) is at
the operators* discretion. Further additional blood will be drawn for the
assessment of biomarkers of ventricular remodelling (BNP, white blood cell
count and HbA1C) within 24 hours of the PPCI. An outpatient visit at 3 months
is part of the usual care after discharge in our institute. An additional visit
at preferably our outpatient clinic at 6 and 12 months with blood sampling for
the follow-up of biomarkers and ventricular remodelling on echocardiogram
and/or CMR is required from participants.
Leyweg 257
Den Haag 2545CH
NL
Leyweg 257
Den Haag 2545CH
NL
Listed location countries
Age
Inclusion criteria
primary PCI, STEMI, multivessel disease, older than 18 years, hemodynamic stable
Exclusion criteria
cardiogenic shock, resucitation, intra-aortic balloon pump, mechanical ventilation, prior infarction or CABG, life expectancy less than 2 years
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46738.098.15 |