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Prophylactic IABP in High-risk Patients Undergoing CABG

U

University of Giessen

Status

Withdrawn

Conditions

Coronary Artery Disease
Myocardial Infarction

Treatments

Procedure: Preoperative IABC

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

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.

Key exclusion criteria:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

IABP group
Experimental group
Description:
Preoperative IABP insertion
Treatment:
Procedure: Preoperative IABC
Control group
No Intervention group
Description:
Preoperative conservative treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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