What side effects are associated with this type of intervention?

Common treatments for cardiac surgery include medications such as beta-blockers, statins, and anticoagulants, as well as procedures like atrial pacing and the use of drains to reduce pericardial effusion. Beta-blockers can cause side effects like fatigue, cold extremities, and bradycardia. Statins may lead to muscle pain, liver enzyme abnormalities, and increased blood sugar levels. Anticoagulants carry risks of bleeding and bruising. Atrial pacing, while generally safe, can sometimes cause discomfort or infection at the pacing wire site. The use of drains can lead to infection or discomfort. Remote, automated monitoring, as studied in the SMArTVIEW trial, aims to reduce readmissions and urgent care visits, but its side effects are minimal, primarily involving the inconvenience or anxiety related to continuous monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments and devices relevant to cardiac surgery and postoperative care. Notably, remote patient monitoring systems like CardioMEMS have been approved to help manage heart failure by tracking pulmonary artery pressure, which can prevent hospital readmissions. Additionally, medications such as statins (e.g., atorvastatin and rosuvastatin) have been approved to reduce the risk of postoperative atrial fibrillation, a common complication after cardiac surgery. These treatments align with the goals of the SMArTVIEW trial, which aims to use remote, automated monitoring to reduce readmissions and urgent care visits.

What other types of research exist?

Promising alternatives to SMArTVIEW for cardiac surgery patients include: 1) Tele-echocardiography, which allows for remote real-time echocardiographic interpretation using commonly available equipment, enhancing diagnostic capabilities and patient monitoring. 2) Advanced RPM programs that utilize non-invasive digital technologies to continuously monitor vital signs and other health metrics, providing timely interventions and reducing hospital readmissions. 3) Integrated telehealth platforms that offer comprehensive care management, including virtual consultations, automated follow-ups, and patient self-triage tools, ensuring continuous care and early detection of complications.

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SMArTVIEW for Post-Cardiac Surgery Monitoring (SMArTVIEW Trial)

N/A

Waitlist Available

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 60 years;

Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the surgical floor;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion. an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the SMArTVIEW program, which uses remote monitoring technology to help patients who have had heart or major blood vessel surgery. The program checks vital signs continuously and provides nurse support through video calls, aiming to reduce hospital readmissions and emergency visits.

Who is the study for?

This trial is for individuals aged 60 or older who have had major cardiac or vascular surgery and are expected to stay in the hospital for at least 48 hours post-op. They must be mentally clear (as shown by a negative CAM test) and able to consent on their own.

What is being tested?

The SMArTVIEW program is being tested, which involves remote, automated monitoring of patients after cardiac or vascular surgery. The goal is to see if it reduces hospital readmissions and emergency visits within 45 days post-surgery compared to standard care.

What are the potential side effects?

Since SMArTVIEW is a monitoring intervention rather than a medication, traditional side effects like those seen with drugs are not applicable. However, there may be issues related to privacy concerns or discomfort with technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I had major heart or blood vessel surgery and was admitted to the hospital afterwards.

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I expect to stay in the hospital for surgery for at least 2 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion. an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion. an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion. an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Readmission Rate

Secondary study objectives

Composite of Major Complications associated with Undetected Hemodynamic Compromise

Econometrics

Process & Implementation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SMArTVIEWExperimental Treatment1 Intervention

Group II: Standard CareActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SMArTVIEW

2018

N/A

~580

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cardiac surgery patients include atrial pacing, placement of pericardial drains, and the use of medications like colchicine to prevent pericarditis. Atrial pacing helps maintain a regular heart rhythm, reducing the risk of postoperative atrial fibrillation. Pericardial drains prevent fluid accumulation around the heart, which can trigger arrhythmias. Colchicine reduces inflammation, further lowering the risk of complications. Remote and automated monitoring, as studied in the SMArTVIEW trial, allows for continuous assessment of a patient's condition, enabling early detection and intervention for complications such as arrhythmias or fluid buildup. This proactive approach is crucial for improving outcomes and reducing readmissions and urgent care visits in cardiac surgery patients.

Management of cardiogenic shock.Improving Care Using a Bidirectional Geriatric Cardiology Consultative Conference.Surgical options for the management of ischemic cardiomyopathy.