Clinical trial NCT05827315: Incidence, Impact and Mechanisms of Perioperative Right VEntricular Dysfunction (IMPRoVE)
Official title: Incidence, Impact and Mechanisms of Perioperative Right VEntricular Dysfunction (IMPRoVE)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Right Ventricular Dysfunction
Keywords: Echocardiography
T1 CMR
Major non-cardiac surgery
Perioperative Complication
Postoperative myocardial injury
Right heart catheterisation
Coronary sinus sampling
Lead sponsor: NHS National Waiting Times Centre Board
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: NHS Greater Glasgow and Clyde
name: Royal London Hospital
First posted: 2023-04-25
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: Heart attacks are relatively rare around the time of surgery, however by measuring blood markers of heart injury, recent research has revealed that heart injury which otherwise may not be immediately obvious is common. Whilst this type of heart injury appears to be strongly linked to patient outcomes (complications, recovery and survival), the causes and potential treatments for it are not well understood.

Our research group has specialist knowledge about the right-hand side of the heart (right-heart) - the side that pumps blood through the lungs - which is less commonly considered or studied around the time of surgery. We have shown in previous studies using magnetic resonance imaging (MRI) scans (specialised whole-body scans which use a magnet rather than X-rays), evidence of right-heart function deteriorating after surgery. We want to test the idea that some of the blood marker evidence of heart injury reflects injury to the right-heart and more importantly that we can protect the right-heart around the time of surgery, reducing injury and improving patient outcomes.

We will examine these questions in the following ways:

1. With patients' permission, we will perform detailed ultrasound scans of the heart (echocardiography), and blood measurement of injury markers in 175 patients undergoing different types of major surgery. This will allow us to assess how common heart injury is (visible on scans of both sides of the heart), whether it makes any difference to a patient's outcome and whether it explains the changes seen in blood markers.
2. We will ask 50 of these patients to undergo MRI scans of the heart pre- and post-operatively to allow us to identify evidence of injury resulting from heart inflammation around the time of surgery. Inflammation is common following surgery and occurs throughout a patient's body - we believe heart inflammation may be responsible for postoperative heart injury.
3. In 10 of these patients, we will seek to obtain blood samples from vessels flowing into the heart (easily obtained from a simple blood sample) and from veins flowing out of the heart, obtained by passing a fine tube into the heart via blood vessels in a patient's neck under X-ray guidance. This will allow us to examine what happens to immune cells as they pass through the heart (i.e., are they activated by heart inflammation?) and better understand the meaning of the changes seen on MRI scans.

This study will give us a better understanding of which patients are likely to suffer heart injury around the time of surgery and how this injury occurs. With this knowledge, future patients could receive personalised treatment plans aimed at preventing injury and improving outcomes. We are not testing any new treatments in this study.

Eligibility criteria: Main echocardiography study

Inclusion Criteria:

1. Provision of informed consent
2. Age \>18 years
3. 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

Exclusion Criteria:

1. Pregnancy
2. On-going participation in any investigational research which could undermine the scientific basis of the study
3. Previous major surgery within three months prior to recruitment
4. Previous participation in the IMPRoVE study at any time
5. Inadequate comprehension of English resulting in inability to comply with instructions while undergoing investigations required for main study and sub-studies.

Additional exclusion criteria applicable to the T1 CMR sub-study includes:

1. Atrial fibrillation at baseline
2. Contraindication to cardiac magnetic resonance imaging (metal work in body etc)
3. Contraindication to IV Gadolinium: acute or chronic renal failure, allergy to contrast

Primary outcomes:
measure: Incidence of postoperative Right ventricular dysfunction (RVD)
timeFrame: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function
measure: Days alive and at home at 30 days postoperatively (DAH30)
timeFrame: Day 30 postoperatively
Secondary outcomes:
measure: Incidence of postoperative left ventricular dysfunction (LVD)
timeFrame: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in LV function
measure: Cardiac biomarkers
timeFrame: BNP and troponin measured preoperatively, on postoperative days 1 and 2 and on day of postoperative echocardiography (occurring on postoperative days 2-4).
measure: Cardiovascular complications
timeFrame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
measure: Renal outcomes
timeFrame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
measure: Pulmonary outcomes
timeFrame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
measure: Infection Outcomes
timeFrame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
measure: Neurological outcomes
timeFrame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: Postoperative day 1,2, day of postoperative echocardiography in all patients. In patients admitted to HDU/ICU, SOFA score will be collected from postoperative day 0-7.
measure: Fifteen-point Quality of Recovery Score (QoR-15)
timeFrame: Pre-operatively and day of postoperative echocardiography (day 2-4 postoperatively).
measure: World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Preoperatively, and at day 30, day 90, and one year postoperatively.
measure: EuroQoL Dimension Health Related Quality of Life Questionnaire (EQ-5D-5L)
timeFrame: Preoperatively, and at day 30, day 90, and one year postoperatively.
Other outcomes:
Locations:
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: National Waiting Times Centre Board
name: Ben Shelley
role: PRINCIPAL_INVESTIGATOR
References: