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Pre-frailty and Rehospitalization in Cardiac Surgery
| Condition or disease | Intervention/treatment |
|---|---|
| Frailty Syndrome Surgery--Complications Coronary Artery Disease Valve Anomalies | Procedure: Elective Cardiac Surgery |
A three-year retrospective study based on a physiotherapy database was conducted, and a sample of 453 patients over 65 years of age was enrolled. All of them had an established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair). Patients with prior neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data were excluded.
According to the hospital protocol, frailty was assessed by the Clinical Frailty Score (CFS) 24 hours before the scheduled elective surgery. We assigned patients into two groups based on this score: non-frail (frailty score 1~3) and pre-frail (frailty score 4) according to their CFS.
If patients experienced adverse cardiovascular events-both during surgery or at the ICU- such as stroke, infection, prolonged mechanical ventilation time of more than 24 hrs, ICU stay of more than 48 hrs or in-hospital death, they were excluded. We decided to exclude these patients as our objective was to evaluate patients without any surgical complications as our group recently had demonstrated that pre-frail patients had worse outcomes after cardiac surgery in a short period of time.
All included patients were analysed for 3 years using data from the hospital and physiotherapy database, which included medical appointments every 6 months after hospital discharge and major adverse cardiovascular events (atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death).
This retrospective study was approved by the Institutional Ethics Committee (number 2.352.465).
| Study Type : | Observational |
| Actual Enrollment : | 453 participants |
| Observational Model: | Other |
| Time Perspective: | Retrospective |
| Official Title: | Pre-frailty Status Increases the Risk of Rehospitalization and Mortality in Patients After Cardiac Surgery Without Complications |
| Actual Study Start Date : | November 1, 2017 |
| Actual Primary Completion Date : | November 1, 2017 |
| Actual Study Completion Date : | July 30, 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Non-Frail
non-frail (frailty score 1~3) according to their CFS. Established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair). Patients with prior neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data were excluded.
|
Procedure: Elective Cardiac Surgery
Surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair).
|
|
Pre-Frail
Pre-frail (frailty score 4) according to their CFS. Established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair). Patients with prior neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data were excluded.
|
Procedure: Elective Cardiac Surgery
Surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair).
|
- Adverse Outcome [ Time Frame: 3 years after hospital discharge ]atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death
| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair).
Exclusion Criteria:
- neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data
| Brazil | |
| Dante Pazzanese Institute of Cardiology | |
| São Paulo, SP, Brazil, 04012-909 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 12, 2019 | ||||
| First Posted Date | May 14, 2019 | ||||
| Last Update Posted Date | May 16, 2019 | ||||
| Actual Study Start Date | November 1, 2017 | ||||
| Actual Primary Completion Date | November 1, 2017 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Adverse Outcome [ Time Frame: 3 years after hospital discharge ] atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Pre-frailty and Rehospitalization in Cardiac Surgery | ||||
| Official Title | Pre-frailty Status Increases the Risk of Rehospitalization and Mortality in Patients After Cardiac Surgery Without Complications | ||||
| Brief Summary | Background: It has been demonstrated that pre-frailty has more adverse outcomes after cardiac surgery, however, data on prognosis and long-term evolution in pre-frailty patients after cardiac surgery without postoperative complications are still scarce. Design: To evaluate the impact of pre-frailty on functional survival in patients after cardiac surgery without complications. | ||||
| Detailed Description |
A three-year retrospective study based on a physiotherapy database was conducted, and a sample of 453 patients over 65 years of age was enrolled. All of them had an established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair). Patients with prior neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data were excluded. According to the hospital protocol, frailty was assessed by the Clinical Frailty Score (CFS) 24 hours before the scheduled elective surgery. We assigned patients into two groups based on this score: non-frail (frailty score 1~3) and pre-frail (frailty score 4) according to their CFS. If patients experienced adverse cardiovascular events-both during surgery or at the ICU- such as stroke, infection, prolonged mechanical ventilation time of more than 24 hrs, ICU stay of more than 48 hrs or in-hospital death, they were excluded. We decided to exclude these patients as our objective was to evaluate patients without any surgical complications as our group recently had demonstrated that pre-frail patients had worse outcomes after cardiac surgery in a short period of time. All included patients were analysed for 3 years using data from the hospital and physiotherapy database, which included medical appointments every 6 months after hospital discharge and major adverse cardiovascular events (atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death). This retrospective study was approved by the Institutional Ethics Committee (number 2.352.465). |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair). | ||||
| Condition |
|
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| Intervention | Procedure: Elective Cardiac Surgery
Surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair).
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
453 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | July 30, 2018 | ||||
| Actual Primary Completion Date | November 1, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 60 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Brazil | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03949439 | ||||
| Other Study ID Numbers | 2.352.465 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mayron Faria de Oliveira, Instituto Dante Pazzanese de Cardiologia | ||||
| Study Sponsor | Instituto Dante Pazzanese de Cardiologia | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Instituto Dante Pazzanese de Cardiologia | ||||
| Verification Date | May 2019 | ||||
