NCT01950130

Brief Summary

Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

September 18, 2013

Last Update Submit

November 12, 2021

Conditions

Myocardial InfarctionCoronary Artery Disease

Keywords

IABPIABCcoronary artery diseaseprophylacticcardiac assist

Outcome Measures

Primary Outcomes (1)

  • 30-day all-cause mortality post CABG [%]

    30 days

Secondary Outcomes (4)

  • Survival at 3, 6, 12 months [%]

    3, 6 and 12 months

  • Duration of ICU stay [h]

    48 hours (average)

  • Dependence on medical inotropic support

    48 hours (average)

  • IABP-associated complications

    8 days (average)

Study Arms (2)

IABP group

EXPERIMENTAL

Preoperative IABP insertion

Procedure: Preoperative IABC

Control group

NO INTERVENTION

Preoperative conservative treatment

Interventions

Preoperative IABCPROCEDURE

IABP-Insertion upon inclusion into the trial and admission to the ICU

IABP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodynamically stable high-risk patients before CABG, defined by the following criteria:
  • Age \>18 years
  • Isolated CABG planned
  • Informed consent in trial participation given
  • Any left ventricular functional impairment (regional wall motion abnormality or global LVEF\<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography
  • Elevated cardiac biomarkers (CK-MB \> 6% of total-CK, Troponin I \> 3-fold of specific test reference) or myocardial infarction (NSTEMI or STEMI) within the last 4 days.

You may not qualify if:

  • Contraindications for IABP
  • Cardiogenic shock
  • Shock of any other cause
  • Critical preoperative state according to EuroSCORE II-criteria
  • Cardiac surgical procedure other than CABG planned
  • Severe comorbidity with life expectancy \< 6 months
  • Incapability of giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Adult and Pediatric Cardiovascular Surgery

Giessen, 35392, Germany

Location

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Philippe Grieshaber, MD

    Giessen University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 18, 2013

First Posted

September 25, 2013

Study Start

June 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2018

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

DE(1)