Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Active, not recruiting

• Conditions: Vascular Death; Stroke; Myocardial Infarction; Cardiac Surgery

• Registration Number: NCT01842568
• Lead Sponsor: Population Health Research Institute

Brief Summary

Worldwide over 2 million adults (\>30,000 Canadians) undergo heart surgery annually. Although heart surgery provides important survival benefits, it is associated with potential major complications such as death, stroke, and heart attack. There is promising evidence that measurement of heart injury markers after surgery will identify patients at risk of death or major complications.

This study will determine the current incidence of major complications in a representative sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current burden of complications will inform clinicians, administrators, government and granting agencies about resources required to address the problem. This study will also establish the role of measuring heart injury markers to identify important heart injury after heart surgery and the proportion that would go undetected without routine heart injury marker monitoring. This information will facilitate further studies of timely interventions. In summary, the VISION Cardiac Surgery Study addresses fundamental questions that will have profound public health implications given the millions of adults worldwide who undergo heart surgery annually.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Study Start: 2013-05
• Primary Completion: 2022-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15989

Inclusion Criteria

1. Age ≥ 18 years.
2. Patients who have undergone cardiac surgery. This includes coronary artery bypass grafting and all open heart procedures such as valvular repairs/replacement.

Exclusion Criteria

1. Previously enrolled in the VISION Cardiac Surgery Study.
2. Patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial injuries that were not identified clinically during the first 5 days after surgery	5 days after surgery	Myocardial injuries that were not identified clinically during the first 5 days after surgery
All-cause mortality at 30-days after surgery	30 days after surgery	All-cause mortality at 30-days after surgery
Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device	1 year after surgery	Major vascular complications at 1-year after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device)

Secondary Outcome Measures

Name	Time	Method
Chronic incisional pain	1 year after surgery	Chronic incisional pain
New dialysis	1 year after surgery	New dialysis
Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device	30 days after surgery	Major vascular complications at 30-days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device)
Total mortality	1 year after surgery	Total mortality
Cardiac transplant	1 year after surgery	Cardiac transplant
Congestive heart failure	1 year after surgery	Congestive heart failure
Frailty	1 year after surgery	Frailty assessed by PRISMA-7 questionnaire
Vascular mortality	1 year after surgery	death due to vascular cause
Myocardial infarction	1 year after surgery	Myocardial infarction
Non-fatal cardiac arrest	1 year after surgery	Non-fatal cardiac arrest
Deep venous thrombosis	1 year after surgery	Deep venous thrombosis
Infection	1 year after surgery	Infection (including sternal, sepsis, pneumonia)
Re-hospitalization for a vascular reason	1 year after surgery	Re-hospitalization for a vascular reason
Stroke	1 year after surgery	Stroke
Implantation of mechanical assist device	1 year after surgery	Implantation of mechanical assist device
Repeat cardiac revascularization procedures	1 year after surgery	Repeat cardiac revascularization procedures
New atrial fibrillation	1 year after surgery	New clinically important atrial fibrillation
Pulmonary embolus	1 year after surgery	Pulmonary embolus
Major bleeding	1 year after surgery	Major bleeding

Trial Locations

Locations (24)

Ronald Reagan Medical Centre, UCLA; 🇺🇸 Los Angeles, California, United States

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

Hospital de Clínicas de Porto Alegre - HCPA; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Instituto de Cardiologia do RS; 🇧🇷 Porto Alegre, RS, Brazil

INCOR; 🇧🇷 São Paulo, Brazil

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

First Teaching Hospital; 🇨🇳 XinJiang, China

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong, SAR, Hong Kong

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