Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00468598
Other study ID # 06/07
Secondary ID
Status Completed
Phase N/A
First received May 2, 2007
Last updated March 9, 2015
Start date January 2007
Est. completion date March 2013

Study information

Verified date March 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

This survey has two aims. First, we would like to be informed about the health condition of our patients two years following heart surgery at University Hospital, Basel. Second, we are interested in determining whether a patient's long-term outcome can be predicted by the analysis of blood samples taken shortly after heart surgery.Troponin T, the blood parameter that we are interested in, is routinely assessed in the Intensive Care Unit. The purpose of this survey is to determine whether or not it is also possible to infer the long-term outcome from this blood parameter.


Description:

Hypothesis and purpose:

The primary hypothesis of this study is that the amount of troponin T release after cardiac surgery is associated with mortality and cardiac morbidity within 1 year after surgery. Patients undergoing coronary procedures using cardiopulmonary bypass (CPB) (i.e., CABG, valvular and combined on-pump procedures) will be analysed.

A further purpose of the study is to evaluate the outcome of patients undergoing cardiac procedures at our institution, as this is currently not quantified.

Study design:

After ethical approval, we will conduct our study in two parts. In the first part, we will perform a retrospective cohort study at the University Hospital Basel to assess the 1 year outcome in all patients who have undergone cardiac surgery at our institution between January 1, 2005 and December 31, 2006. In addition, we will identify the best cut-off value of postoperative troponin T for predicting morbidity and mortality 1 year after open-heart surgery.

The second part of the study will be performed between January 1, 2007 and December 31, 2008. We will continue the quality control study and will prospectively test the clinical value of elevated troponin T values, according to the risk model developed in the first part, for predicting for long-term (1 year) morbidity and mortality. The prospective part of the study can include patients operated on as early as January 1, 2007 because the prospective follow-up will take place 12 months after surgery.

Patient selection:

Inclusion criteria: all patients who underwent or will undergo cardiac surgery using cardio-pulmonary bypass at the University Hospital Basel between January 1, 2005 and December 31, 2008 will be eligible.

For the first part of the study, patients who had cardiac surgery between January 1, 2005 and December 31, 2006 will be analysed retrospectively.

For the prospective part of the study, all patients will be studied who will have surgery between January 1, 2007 and December 31, 2008.

Exclusion criteria:

- Cardiac surgery without the use of cardiopulmonary bypass

- Procedures requiring circulatory arrest

- Penetrating cardiac trauma

- Lack of informed consent.

Baseline variables:

Relevant patient data including: history, functional state, medication, EuroSCORE8, and haematological, basic renal, hepatic and metabolic chemistry findings (the routinely performed preoperative laboratory tests in our institution, including preoperative C-reactive protein and troponin T in the presence of a recent (<7 days) ACS will be collected in the retrospective as well as in the prospective cohorts. Pre-operative 12-lead ECG will only be analysed in the prospective cohort.

Peri-operative surgical and clinical variables:

Surgical procedures and techniques, operative data (operating time, blood loss, cardiopulmonary and cross-clamp time, number of arterial and venous grafts and number of distal anastomoses) will be assessed. Early postoperative therapy or events in the intensive care unit, including total time on mechanical ventilation, postoperative inotropic support, blood transfusion and renal replacement therapy, lengths of intensive care unit and hospital stay, re-operation, new onset ventricular arrhythmia and Q-wave PMI will be recorded in both parts of the study study.

Cardiac marker analyses and 12-lead ECG:

Troponin T levels, routinely measured on the first and second postoperative day, will be used for analysis in both parts of the study. Also, the routinely registered 12-lead ECG at discharge will be compared with the preoperative baseline ECG and evaluated for ischemic changes according to the Minnesota criteria for Q- and R-waves as well as for ST-deviation and T-wave changes in the prospective cohort.

Clinical endpoints:

Primary endpoint: All-cause mortality within one year after surgery.

Secondary endpoint: Major adverse cardiac events, defined as cardiac mortality, myocardial infarction, congestive heart failure requiring hospitalisation and need for surgical or percutaneous coronary intervention within 1 year.

The outcome measures will be obtained by reviewing hospital charts and by direct telephone contact with the patients.

Sample Size:

For the retrospective part, we anticipate a sample size of 1000 patients for the planned study period of 24 months. Estimating a 1-year mortality of 6%, we expect 60 adverse events. This number of adverse events will allow for a statistically robust multivariate risk model based on 6 variables. We assume that a sample size of 660 patients will allow for retesting of the model in the prospective part of the study.

Statistical Analysis:

Analyses will be performed for the whole cohort as well as separately for patients with each type of cardiac surgery, i.e., for patients undergoing CABG, aortic valve surgery, mitral valve surgery, combined surgeries (CABG plus valve surgery) and for patients with a recent(<7 days) ACS before surgery.

Continuous data will be presented as mean ± SD and comparison between groups calculated by an unpaired t-test. Categorical data will be presented as absolute numbers and percentages and comparisons calculated by Pearson's χ2 test. Receiver operating characteristics curves will be computed to establish cut-off values of troponin T and its likelihood ratio for the outcome measures.

Multivariate logistic regression will be used to adjust the association of troponin T elevation and outcome for established clinical risk parameters. This risk model, developed in the retrospective first part of the study, will thereafter be retested in the prospective second part.

A p value <0.05 will be defined as pointing to significance. All analyses will be calculated by SPSS Version 14.


Recruitment information / eligibility

Status Completed
Enrollment 3000
Est. completion date March 2013
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- On-pump cardiac surgery at University Hospital of Basel

Exclusion Criteria:

- Off-pump cardiac surgery

- Procedures requiring hypothermic cardiocirculatory arrest

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University Hospital Basel Basel-Stadt

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death and/or major adverse cardiac events 12 months after cardiac surgery Yes
See also
  Status Clinical Trial Phase
Recruiting NCT01352416 - Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery N/A
Completed NCT01553617 - VolulyteTM in Cardiac Surgery Phase 4
Completed NCT01353157 - Study of the Clinical Scoring System and Cytokines for Prediction of Inflammatory Response in Major Surgery N/A
Active, not recruiting NCT02224222 - Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery
Completed NCT01382758 - Near Infrared Spectroscopy for the Detection of Acute Kidney Injury in Children Following Cardiac Surgery N/A
Completed NCT01816581 - Oral Oxycodone After Major Cardiac Surgery Phase 4
Terminated NCT01397331 - Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery Phase 4
Completed NCT01913873 - High-sensitivity Troponin in Cardiac Surgery Phase 4
Completed NCT01289470 - Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery N/A
Recruiting NCT03469440 - Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery N/A
Completed NCT02371863 - Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR N/A
Completed NCT05038267 - Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study
Not yet recruiting NCT02524353 - Follow-up Study of Patients Undergoing Cardiac Surgery N/A
Terminated NCT02210949 - Pre-operative Treatment With Erythropoietin and Iron Supplement in Cardiac Surgery Phase 4
Completed NCT01559870 - Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery N/A
Recruiting NCT01258231 - Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
Completed NCT01457898 - Non-invasive Mechanical Ventilation After Cardiac Surgery N/A