Incidence, Impact and Mechanisms of Perioperative Right VEntricular Dysfunction (IMPRoVE)
IMPRoVE
1 other identifier
observational
175
1 country
3
Brief Summary
A study to see how common right heart failure (right ventricular dysfunction) after major surgery is, and to investigate if right ventricular dysfunction causes worse patient outcomes after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Typical duration for all trials
3 active sites
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
March 27, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedApril 25, 2023
April 1, 2023
3 years
March 27, 2023
April 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of postoperative Right ventricular dysfunction (RVD)
RVD diagnosed by transthoracic echocardiography, defined as: * 2D-speckle tracking derived RV free wall peak longitudinal strain (FWLS) less negative than -20%. * Or, (where not available) two of Tricuspid Annular Plane Systolic Excursion (TAPSE) \<16mm, S' Wave velocity at the tricuspid annulus \<10cm/s or tissue doppler RV index of myocardial performance \>0.55
Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function
Days alive and at home at 30 days postoperatively (DAH30)
DAH30 is a continuous number between 0 and 30 which reflects, out of the 30 days following surgery, the total number of those days that a patient spends alive and at home. If a patient dies within those 30 days, their value is set to 0. Data for DAH30 will be obtained by follow-up phone calls following the 30th postoperative day.
Day 30 postoperatively
Secondary Outcomes (11)
Incidence of postoperative left ventricular dysfunction (LVD)
Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in LV function
Cardiac biomarkers
BNP and troponin measured preoperatively, on postoperative days 1 and 2 and on day of postoperative echocardiography (occurring on postoperative days 2-4).
Cardiovascular complications
Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Renal outcomes
Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Pulmonary outcomes
Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
- +6 more secondary outcomes
Study Arms (5)
Thoracic surgery cohort
35 patients undergoing thoracic surgery with lung resection and one lung ventilation under primarily general anaesthesia.
Upper gastrointestinal surgery cohort
35 patients undergoing upper gastrointestinal surgery with one lung ventilation under primarily general anaesthesia.
Colorectal surgery cohort
35 patients undergoing elective colorectal surgery under primarily general anaesthesia.
Vascular surgery cohort
35 patients undergoing elective open abdominal aortic surgery under primarily general anaesthesia.
Orthopaedic surgery cohort
35 patients undergoing elective primary hip or knee arthroplasty under spinal anaesthesia +/- sedation.
Interventions
Echocardiography will be performed by BSE accredited echocardiographers in all 175 patients preoperatively and on day 2-4 postoperatively.
T1 CMR will be performed in 10 patients from each of the 5 surgical groups (50 patients in total) preoperatively and on day 2-4 postoperatively.
10 patients from the thoracic surgical group will undergo right heart catheterisation and coronary sinus blood sampling.
Eligibility Criteria
175 patients of 18 years or older undergoing major non-cardiac surgery in the West of Scotland. Patients will be recruited from the Golden Jubilee National Hospital, Queen Elizabeth University Hospital, and Glasgow Royal Infirmary.
You may qualify if:
- Provision of informed consent
- Age \>18 years
- Planned elective primary hip or knee joint replacement under spinal anaesthesia, major colorectal, major vascular surgery or surgery requiring one lung ventilation with or without lung resection
You may not qualify if:
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Previous major surgery within three months prior to recruitment
- Previous participation in the IMPRoVE study at any time
- Inadequate comprehension of English resulting in inability to comply with instructions while undergoing investigations required for main study and sub-studies.
- Atrial fibrillation at baseline
- Contraindication to cardiac magnetic resonance imaging (metal work in body etc)
- Contraindication to IV Gadolinium: acute or chronic renal failure, allergy to contrast
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS National Waiting Times Centre Boardlead
- University of Glasgowcollaborator
- NHS Greater Glasgow and Clydecollaborator
- Royal London Hospitalcollaborator
Study Sites (3)
Golden Jubilee National Hospital
Clydebank, United Kingdom
Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Related Publications (1)
Keast T, McErlane J, Kearns R, McKinlay S, Raju I, Watson M, Robertson KE, Berry C, Greenlaw N, Ackland G, McCall P, Shelley B. Study protocol for IMPRoVE: a multicentre prospective observational cohort study of the incidence, impact and mechanisms of perioperative right ventricular dysfunction in non-cardiac surgery. BMJ Open. 2023 Sep 6;13(9):e074687. doi: 10.1136/bmjopen-2023-074687.
PMID: 37673452DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ben Shelley
National Waiting Times Centre Board
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Professor/Consultant in Cardiothoracic Anaesthesia and Intensive Care
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 25, 2023
Study Start
April 1, 2023
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
April 25, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share