Pre-Frailty Risk in Cardiovascular Surgery

NCT02829203 | Completed

• 1 other identifier: 4560
• Study Type: observational
• Target: 221
• Locations: 0 countries
• Sites: N/A

Brief Summary

Frailty is an important risk factor for cardiovascular disease (CVD), recent data has shown significant association between pre-frailty and the risk of incident for CVD, irrespective of any classical cardiometabolic risk factors, suggesting that targeting pre-frailty as a potentially reversible risk factor for CVD in the elderly. Patients with high levels of frailty have an increased risk in post-operative period, with more time in mechanical ventilation, length of stay and complications (stroke and death) compared to patients with low frailty levels. The investigators hypothesized that pre-frailty patients also have a higher surgical risk compared to no-frailty patients.

Conditions

Post Cardiac Surgery

Keywords

Frailty; Surgery

Outcome Measures

Primary Outcomes (1)

• Cardiac outcome in patients with or without frailty score

  6 months

Study Arms (2)

No-Frailty

Patients without frailty score submitted to a cardiac surgery

Pre-Frailty

Patients with pre-frailty score submitted to a cardiac surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an established diagnosis of cardiovascular diseases (myocardial infarction or valve regurgitation) by previous electrocardiogram and/or Doppler echocardiography and all had surgical indication (coronary artery bypass, valve replacement or combined surgery). Patients with prior neurological disease (previous stroke or muscular dystrophies) or cognitive impairment resulting from previous injury or who refused to participate in the study were excluded. Twenty-four hours before the surgery patients were evaluated by Frailty score as described elsewhere and divided into 2 groups: No-Frailty (Frailty score 1 or 2) and Pre-Frailty (Frailty score 3 or 4). If the patient had Frailty score ≥ 5 they were excluded from the study.

You may qualify if:

• cardiovascular diseases (myocardial infarction or valve regurgitation) by previous electrocardiogram and/or Doppler echocardiography and all had surgical indication (coronary artery bypass, valve replacement or combined surgery).

You may not qualify if:

• neurological disease (previous stroke or muscular dystrophies) or cognitive impairment resulting from previous injury or who refused to participate in the study

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 12, 2016
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share