Pre-frailty and Rehospitalization in Cardiac Surgery

NCT03949439 | Completed

• 1 other identifier: 2.352.465
• Study Type: observational
• Target: 453
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome; Surgery--Complications; Coronary Artery Disease; Valve Anomalies

Keywords

Frailty; Cardiac Suregry; Adverse Events

Outcome Measures

Primary Outcomes (1)

• Adverse Outcome

  atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death

  3 years after hospital discharge

Study Arms (2)

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

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

Interventions

Elective Cardiac Surgery PROCEDURE

Surgical interventions (coronary artery bypass \[CAB\], valve replacement or valve repair).

Non-Frail; Pre-Frail

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead

Study Sites (1)

Dante Pazzanese Institute of Cardiology

São Paulo, São Paulo, 04012-909, Brazil

Location

MeSH Terms

Conditions

Frailty; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: May 14, 2019
• Study Start: November 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: July 30, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)