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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06175650
Other study ID # W22_051 # 22.082
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 21, 2023
Est. completion date November 21, 2026

Study information

Verified date December 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Jennifer S Breel, MSc
Phone +31610019257
Email j.s.breel@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the differences between men and women undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at 30 and 90 days, 1, 5, and 10 years.


Description:

Observational, multicentre, retrospective data collection from the mandatory Quality Assurance database (the Netherlands Heart Registry, (NHR), supplemented with data from the electronic patient files (EPIC). The retrospective data is already available. In addition, we will continue the retrospective study into a prospective registry of data after the analysis of the retrospective data. Patients will be approached one, five and ten years after the operation and a questionnaire will be sent to document quality of life. No research-related interventions other than questionnaires will be performed


Recruitment information / eligibility

Status Recruiting
Enrollment 5500
Est. completion date November 21, 2026
Est. primary completion date November 21, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients > 18 years - All patients who underwent cardiac surgery from 1 January 2016 to the start of the study, in either of the centres (AMC or VUmc) (retrospective) - All patients undergoing cardiac surgery from the start of the study (~March 2022) until approximately 2032 Exclusion Criteria: • Patients who object to the re-use of their care data or do not give consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiac surgery
Cardiac surgery of all types

Locations

Country Name City State
Netherlands Academic Medical Center Amsterdam North Holland

Sponsors (1)

Lead Sponsor Collaborator
Jennifer Breel

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Cho L, Kibbe MR, Bakaeen F, Aggarwal NR, Davis MB, Karmalou T, Lawton JS, Ouzounian M, Preventza O, Russo AM, Shroyer AW, Zwischenberger BA, Lindley KJ. Cardiac Surgery in Women in the Current Era: What Are the Gaps in Care? Circulation. 2021 Oct 5;144(14):1172-1185. doi: 10.1161/CIRCULATIONAHA.121.056025. Epub 2021 Oct 4. — View Citation

Dixon LK, Di Tommaso E, Dimagli A, Sinha S, Sandhu M, Benedetto U, Angelini GD. Impact of sex on outcomes after cardiac surgery: A systematic review and meta-analysis. Int J Cardiol. 2021 Nov 15;343:27-34. doi: 10.1016/j.ijcard.2021.09.011. Epub 2021 Sep 11. — View Citation

Nanegrungsunk D, Patel S, Jan T, Ngai JY. Preoperative Care Practice for Female Cardiac Patients: A Survey From the Society of Cardiovascular Anesthesiologists. J Cardiothorac Vasc Anesth. 2022 Mar;36(3):920-921. doi: 10.1053/j.jvca.2021.09.054. Epub 2021 Oct 3. No abstract available. — View Citation

Peters SAE, Kluin J. Why do women do worse after coronary artery bypass grafting? Eur Heart J. 2021 Dec 28;43(1):29-31. doi: 10.1093/eurheartj/ehab617. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary endpoint Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc up to 30 days post-surgery
Primary Primary endpoint incidence of cerebrovascualar accident with neurological sequelae (number of patients) up to 30 days post-surgery
Primary Primary endpoint incidence of acute kidney injury (number of patients) up to 30 days post-surgery
Primary Primary endpoint incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation > 48 hours post-operatively) up to 30 days post-surgery
Primary Primary endpoint Number of specific (coagulation), transfusion products, up to 30 days post-surgery
Primary Primary outcome Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc. up to 30 days post-surgery or if still in hospital, until discharge
Secondary Morbidity and mortality peroperative and post-operative complications At 30, 90, 365 days
Secondary Survival Long term survival At 5 and 10 years
Secondary Health related Quality of life measured by PROMS Long term quality of life after cardiac surgery, measured by Seattle Angina Questionaire (SAQ), EuroQol Quality of life (EQ-5D-5L) and Coronary Revascularisation Outcome Questionnaire (CROQ) or other appropriate questionnaire At 1, 5 and 10 years
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