To examine whether culprit lesion only percutaneous coronary intervention (PCI) with subsequent staged revascularization is beneficial over immediate multivessel revascularization by PCI for patients with cardiogenic shock complicating acute…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
30-day mortality and/or severe renal failure requiring renal replacement
therapy [ Time Frame: 30 days ]
Secondary outcome
30-day mortality [ Time Frame: 30 days ]
Requirement of renal replacement therapy [ Time Frame: 30 days ]
Time to hemodynamic stabilization [ Time Frame: 30 days ]
Duration of catecholamine therapy [ Time Frame: 30 days ]
Serial creatinine-level creatinine-clearance [ Time Frame: 30 days ]
Length of ICU-stay [ Time Frame: 30 days ]
Serial intensive care scoring (SAPS-II score) until stabilization [ Time Frame:
30 days ]
Requirement and length of mechanical ventilation [ Time Frame: 30 days ]
All-cause death within 12 months follow-up [ Time Frame: 12 months ]
Recurrent infarction within 30-days follow-up [ Time Frame: 30 days ]
Death or recurrent infarction at 12 months follow-up [ Time Frame: 12 months ]
Rehospitalization for congestive heart failure within 12 months follow-up [
Time Frame: 12 months ]
Death/recurrent infarction/rehospitalization for congestive heart failure
within 12 months [ Time Frame: 12 months ]
Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up
[ Time Frame: 12 months ]
Peak creatine kinase level during hospital stay [ Time Frame: 30 days ]
Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D) [ Time
Frame: 12 months ]
Maximum creatine kinase-MB level [ Time Frame: 30 days ]
Maximum troponin level [ Time Frame: 30 days ]
Recurrent infarction within 12 months follow-up [ Time Frame: 12 months ]
Background summary
Despite aggressive treatment modalities such as PCI as well as mechanical and
inotropic support, mortality of cardiogenic shock complicating acute myocardial
infarction remains at a very high level with mortality rates between 45-70%.The
majority of patients in cardiogenic shock presents with multivessel coronary
artery disease and the mortality of these patients is higher than mortality in
patients with single vessel disease.From a pathophysiological standpoint it
might be beneficial to reperfuse all relevant coronary arteries with
significant coronary artery stenoses in addition to the culprit lesion to
improve myocardial perfusion. On the other hand immediate multivessel PCI might
pose additional risk for the patients. However, there are no randomized
clinical trials assessing the optimal reperfusion strategy.
Study objective
To examine whether culprit lesion only percutaneous coronary intervention (PCI)
with subsequent staged revascularization is beneficial over immediate
multivessel revascularization by PCI for patients with cardiogenic shock
complicating acute myocardial infarction with respect to 30-day mortality
and/or severe renal failure requiring renal replacement therapy.
Study design
Prospective, controlled, international, multicenter, randomized, open-label
Intervention
Immediate multivessel PCI
Culprit lesion only PCI
Study burden and risks
It may also be hypothesized that multivessel PCI may reduce the subsequent
adverse events after primary PCI by preventing the incidence of both early and
late recurrent ischemia in the non-infarct related lesions, which in turn could
obviate the need for recurrent procedures, reducing overall ischemic burden and
attenuating the incidence of unpredictable subsequent cardiac events. Complete
revascularization at the time of infarction may also reduce overall hospital
stay and total cost of care. On the other hand, major concern exists regarding
the risks of prolonged interventional procedures with higher amounts of
contrast dye and the hypothetical risk of stent thrombosis in non-culprit
lesions when stent implantation has taken place in the thrombogenic milieu of
acute myocardial infarction. A successful primary PCI of the infarct related
artery and a complicated or unsuccessful PCI to the non-infarct related artery
would be potentially hazardous, especially in the setting of cardiogenic shock
The risks associated with participation in the study are equivalent of those
associated with standard (primary) PCI in patients with cardiogenic shock. The
patient burden consists of the possibility that patients who are deferred for
complete revascularization need to be scheduled for additional percutaneous
coronary intervention if significant signs of cardiac ischemia persist,
additionally the patient will be contacted by telephone at 30 days, 6 months
and 12 months follow up.
Ratzeburger Allee 160
Lubeck D-23562
DE
Ratzeburger Allee 160
Lubeck D-23562
DE
Listed location countries
Age
Inclusion criteria
Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI) with
obligatory:;1. Planned early revascularization by PCI;2. Multivessel coronary artery disease defined as >70% stenosis in at least 2 major
vessels (>=2 mm diameter) with identifiable culprit lesion;3. a Systolic blood pressure <90 mmHg for >30 min or
b catecholamines required to maintain pressure >90 mmHg during systole and;4. Signs of pulmonary congestion;5. Signs of impaired organ perfusion with at least one of the following criteria
a) Altered mental status
b) Cold, clammy skin and extremities
c) Oliguria with urine output <30 ml/h
d) Serum-lactate >2.0 mmol/l;6. Informed consent
Exclusion criteria
1. Resuscitation >30 minutes;2. No intrinsic heart action;3. Cerebral deficit with fixed dilated pupils (not drug-induced);4. Need for primary urgent bypass surgery (to be determined after diagnostic angiography);5. Single vessel disease;6. Mechanical cause of cardiogenic shock;7. Onset of shock >12 h;8. Massive lung emboli;9. Age >90 years;10. Shock of other cause (bradycardia, sepsis, hypovolemia, etc.);11. Other severe concomitant disease with limited life expectancy <6 months;12. Pregnancy;13. Known severe renal insufficiency (creatinine clearance <30 ml/kg)
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT01927549 |
| CCMO | NL47279.018.14 |