Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-frailty and Rehospitalization in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949439
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mayron Faria de Oliveira, Instituto Dante Pazzanese de Cardiologia

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.

Condition or disease Intervention/treatment
Frailty Syndrome Surgery--Complications Coronary Artery Disease Valve Anomalies Procedure: Elective Cardiac Surgery

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).

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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).




Primary Outcome Measures :
  1. Adverse Outcome [ Time Frame: 3 years after hospital discharge ]
    atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949439


Locations
Layout table for location information
Brazil
Dante Pazzanese Institute of Cardiology
São Paulo, SP, Brazil, 04012-909
Sponsors and Collaborators
Instituto Dante Pazzanese de Cardiologia
Layout table for additonal information
Responsible Party: Mayron Faria de Oliveira, Clinical Professor, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT03949439    
Other Study ID Numbers: 2.352.465
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Submit the paper to a medical journal

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mayron Faria de Oliveira, Instituto Dante Pazzanese de Cardiologia:
Frailty
Cardiac Suregry
Adverse Events
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Frailty
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes