3D & Speckle Tracking Together as a Marker for Early Outcome in Cardiac Surgery

NCT02642770 | Completed

• 1 other identifier: NK/2440/DM/2266
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Patients presenting with Left Ventricle (LV) dysfunction undergoing cardiac surgery are at increased risk of perioperative morbidity and mortality. LV dysfunction has been reported as an independent predictor of operative mortality in patients undergoing Cardiac surgery. It also often leads to low cardiac output states with many of these patients requiring inotropic or mechanical support and vasopressors for hours to days after surgery. Speckle tracking when combined with three dimensional (3D) imaging techniques might prove to be a more sensitive marker for ventricular dysfunction. The present study investigates early outcomes in a consecutive series of patients with LV dysfunction undergoing cardiac surgery

Conditions

Left Ventricular Systolic Dysfunction

Keywords

Transesophageal echocardiography, Speckle tracking strain

Outcome Measures

Primary Outcomes (1)

• incidence of Low Cardiac Output Syndrome

  Vassopressors Ionotropic Score (VIS) ≥ 15 (\> 30 mins) or Requirement of Intra aortic balloon counterpulsation (IABP) in Intensive Care Unit.

  48 hrs

Secondary Outcomes (1)

• Duration of Mechanical Ventilation or Mortality

  5 days

Interventions

Transesophageal echocardiography DEVICE

2D LV Speckle tracking strain and 3D LVEF measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with left ventricular dysfunction (LVEF\< 50%) undergoing cardiac surgery under CPB.

You may qualify if:

• Adult patients (\>18yrs) with moderate to severe LV dysfunction (EF\< 50%) planned for Coronary artery bypass graft (CABG) and/or valve repair/replacement, presenting to our center for elective or emergent surgery will be included in the study.

You may not qualify if:

• Hypertrophic cardiomyopathy
• Sepsis
• Preoperative renal impairment (serum creatinine 2.0 mg/ dL)
• Off pump CABG
• Redo surgery.
• Failed placement despite 3-4 attempts.
• Congenital heart lesions

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160101, India

Location

Related Publications (1)

• Ding W, Ji Q, Shi Y, Ma R. Predictors of low cardiac output syndrome after isolated coronary artery bypass grafting. Int Heart J. 2015;56(2):144-9. doi: 10.1536/ihj.14-231. Epub 2015 Feb 23.

  PMID: 25740396 BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• GD Puri, Prof

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Cardiac Anaesthesia

Study Record Dates

• First Submitted: December 26, 2015
• First Posted: December 30, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

IN (1)