Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock

Acute Myocardial Infarction Clinical Trial

— CULPRIT-SHOCK  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927549
• Other study ID #: CULPRIT-SHOCK1.2
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2013
• Last updated: November 7, 2017
• Start date: April 2013
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

1. Systolic blood pressure less than 90 mmHg for more than 30 min or

2. 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)

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiogenic Shock
• Complications
• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Procedure:
• Immediate multivessel PCI

• Culprit Lesion only PCI

Locations

Country	Name	City	State
Germany	University of Goettingen	Goettingen
Germany	Heart Center Leipzig - University Hospital	Leipzig
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (5)

Lead Sponsor	Collaborator
University of Luebeck	Deutsche Stiftung für Herzforschung, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), European Commission, German Cardiac Society

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality and/or severe renal failure requiring renal replacement therapy		30 days
Secondary	30-day mortality		30 days
Secondary	Requirement of renal replacement therapy		30 days
Secondary	Time to hemodynamic stabilization		30 days
Secondary	Duration of catecholamine therapy		30 days
Secondary	Serial creatinine-level creatinine-clearance		30 days
Secondary	Length of ICU-stay		30 days
Secondary	Serial intensive care scoring (SAPS-II score) until stabilization		30 days
Secondary	Requirement and length of mechanical ventilation		30 days
Secondary	All-cause death within 12 months follow-up		12 months
Secondary	Recurrent infarction within 30-days follow-up		30 days
Secondary	Death or recurrent infarction at 12 months follow-up		12 months
Secondary	Rehospitalization for congestive heart failure within 12 months follow-up		12 months
Secondary	Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months		12 months
Secondary	Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up		12 months
Secondary	Peak creatine kinase level during hospital stay		30 days
Secondary	Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D)		12 months
Secondary	Maximum creatine kinase-MB level		30 days
Secondary	Maximum troponin level		30 days
Secondary	Recurrent infarction within 12 months follow-up		12 months

External Links

•   eCRF and randomization site