Relationship Between Strain and Stroke Volume in Cardiac... | NCT04694378

Studies
Relationship Between Strain and Stroke Volume in Cardiac Surgery

NCT04694378

Sponsor

Tufts Medical Center

Status

Completed

Last Update Posted

Apr 25, 2024Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Right Ventricular Dysfunction
Stroke Volume Index
Longitudinal Heart Strain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Nov 1, 2022Actual

First Submitted Date

Dec 16, 2020

First Submission Date that Met QC Criteria

Jan 2, 2021

First Posted Date

Jan 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2024

Last Update Posted Date

Apr 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment.

Aim:

Investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery

Hypothesis:

Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery
Echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of right ventricular function during CABG assessed by right heart strain (%)	Assessing the change of RV function during CABG surgery using right heart strain as a percentage of change between RV shortening and RV end diastolic length.	during CABG surgery
Change of right ventricular function during CABG assessed by stroke volume index (mL/m2)	Assessing the change of RV function during CABG surgery using stroke volume index. Stroke volume index measurement as millilitres per square meter (ml/m2)	during CABG surgery

Secondary Outcomes

Measure	Description	Time Frame
Change in cardiac output measured with Swan-Ganz during CABG	Cardiac output (L/min) measured with the thermodilution technique	during CABG surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring.

Exclusion Criteria:

Patients with contraindication to Swan-Ganz catheter placement,
Pre-existing atrial arrhythmias,
Patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation
Patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male and female patients older that 18 years old.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tufts Medical Center		Boston	Massachusetts	06111	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018497	Ventricular Dysfunction, Right

Ancestor Terms

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided