NCT Number: NCT01927549
Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock
The study compares the therapies of instant multivessel balloon angioplasty plus stent implantation or the balloon angioplasty plus stent implantation of the infarct artery alone with any possible graduated later treatment of the other vessels in patients with acute myocardial infarction with cardioganic shock.
The main study hypothesis is to explore if culprit vessel only PCI with potentially subsequent staged revascularization in comparison to immediate multivessel revascularization by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces the incidence of 30- day mortality and/or severe renal failure requiring renal replacement therapy.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
University of Goettingen, Göttingen, Germany
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI) with obligatory:
I) Planned early revascularization by PCI II) Multivessel coronary artery disease defined as more than 70% stenosis in at least 2 major vessels (more than 2 mm diameter) with identifiable culprit lesion III)
- Systolic blood pressure less than 90 mmHg for more than 30 min or
- catecholamines required to maintain pressure more than 90 mmHg during systole and IV) Signs of pulmonary congestion V) 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 less than 30 ml/h d) Serum-lactate more than 2.0 mmol/l VI) Informed consent
Exclusion criteria
- Resuscitation more than 30 minutes
- No intrinsic heart action
- Cerebral deficit with fixed dilated pupils (not drug-induced)
- Need for primary urgent bypass surgery (to be determined after diagnostic angiography)
- Single vessel disease
- Mechanical cause of cardiogenic shock
- Onset of shock more than 12 h
- Massive lung emboli
- Age more than 90 years
- Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
- Other severe concomitant disease with limited life expectancy <6 months
- Pregnancy
- Known severe renal insufficiency (creatinine clearance <30 ml/kg)
Treatment and study plan
Culprit lesion only PCI
ProcedurePrimary outcomes
-
30-day mortality and/or severe renal failure requiring renal replacement therapy
Time frame: 30 days
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University of Luebeck
Other
Collaborators
- Deutsche Stiftung für Herzforschung
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- European Commission
- German Cardiac Society
Registry information
Official study title
Prospective Randomized Multicenter Study Comparing Immediate Multivessel Revascularization by PCI Versus Culprit Lesion PCI With Staged Non-culprit Lesion Revascularization in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Acronym: CULPRIT-SHOCK
Important dates
- Study start
- 2013
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Aug 22, 2013
- Registry last updated
- Nov 9, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock
NCT06006754
Acute Heart Failure, Acute Myocardial Infarction
Essen, North Rhine-Westphalia, Germany
View Trial DetailsNational Cardiogenic Shock Initiative
NCT03677180
Acute Myocardial Infarction, Cardiogenic Shock
Birmingham, Alabama, United States
View Trial DetailsEffect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction
NCT06947616
Acute Myocardial Infarction, Cardiogenic Shock
Tanta, El-Gharbia, Egypt
View Trial DetailsDual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction
NCT03551964
Acute Myocardial Infarction, Cardiogenic Shock
Prague, Please Select, Czechia
View Trial Details