Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Stroke Clinical Trial

Official title:

Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01842568
• Other study ID #: VISION Cardiac Surgery
• Status: Active, not recruiting
• Start date: May 2013
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15989
• Est. completion date: December 2023
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Infarction
• Myocardial Infarction
• Stroke
• Vascular Death

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Brazil	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
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
China	First Teaching Hospital	XinJiang
Hong Kong	Prince of Wales Hospital	Shatin	Hong Kong, SAR
Italy	Santa Maria Hospital, GVM Care and Research	Bari
Italy	University of Bari "Aldo Moro"	Bari
Italy	San Raffaele Scientific Institute	Milan
Malaysia	Institut Jantung Negara Sdn. Bhd.	Kuala Lumpur
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Poland	Department of Cardiovascular Surgery, Medical University of Gdansk	Gdansk
Russian Federation	Federal State Budgetary Institution "Research Institute for Complex Issues of Cardiovascular Diseases"	Kemerovo
Russian Federation	Research Institute of Circulation Pathology	Novosibirsk
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
United Kingdom	Essex Cardiothoracic Centre, Basildon and Thurrock University NHS Trust	Basildon	Essex
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust	Blackpool	Lancashire
United Kingdom	BHF Centre of Cardiovascular Science, University of Edinburgh	Edinburgh
United Kingdom	Liverpool Heart and Chest Hospital NHS Foundation Trust	Liverpool	Merseyside
United Kingdom	New Cross Hospital	Wolverhampton
United States	Ronald Reagan Medical Centre, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Abbott Diagnostics Division

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  Hong Kong,  Italy,  Malaysia,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality at 30-days after surgery	All-cause mortality at 30-days after surgery	30 days after surgery
Primary	Myocardial injuries that were not identified clinically during the first 5 days after surgery	Myocardial injuries that were not identified clinically during the first 5 days after surgery	5 days after surgery
Primary	Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device	Major vascular complications at 30 days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device)	30 days after surgery
Primary	Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device	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)	1 year after surgery
Secondary	Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device	Major vascular complications at 30-days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device)	30 days after surgery
Secondary	Total mortality	Total mortality	30 days after surgery
Secondary	Total mortality	Total mortality	1 year after surgery
Secondary	Vascular mortality	death due to vascular cause	30 days after surgery
Secondary	Vascular mortality	death due to vascular cause	1 year after surgery
Secondary	Myocardial infarction	Myocardial infarction	30 days after surgery
Secondary	Myocardial infarction	Myocardial infarction	1 year after surgery
Secondary	Non-fatal cardiac arrest	Non-fatal cardiac arrest	30 days after surgery
Secondary	Non-fatal cardiac arrest	Non-fatal cardiac arrest	1 year after surgery
Secondary	Stroke	Stroke	30 days after surgery
Secondary	Stroke	Stroke	1 year after surgery
Secondary	Implantation of mechanical assist device	Implantation of mechanical assist device	30 days after surgery
Secondary	Implantation of mechanical assist device	Implantation of mechanical assist device	1 year after surgery
Secondary	Cardiac transplant	Cardiac transplant	30 days after surgery
Secondary	Cardiac transplant	Cardiac transplant	1 year after surgery
Secondary	Repeat cardiac revascularization procedures	Repeat cardiac revascularization procedures	30 days after surgery
Secondary	Repeat cardiac revascularization procedures	Repeat cardiac revascularization procedures	1 year after surgery
Secondary	Congestive heart failure	Congestive heart failure	30 days after surgery
Secondary	Congestive heart failure	Congestive heart failure	1 year after surgery
Secondary	New atrial fibrillation	New clinically important atrial fibrillation	30 days after surgery
Secondary	New atrial fibrillation	New clinically important atrial fibrillation	1 year after surgery
Secondary	Pulmonary embolus	Pulmonary embolus	30 days after surgery
Secondary	Pulmonary embolus	Pulmonary embolus	1 year after surgery
Secondary	Deep venous thrombosis	Deep venous thrombosis	30 days after surgery
Secondary	Deep venous thrombosis	Deep venous thrombosis	1 year after surgery
Secondary	Major bleeding	Major bleeding	30 days after surgery
Secondary	Major bleeding	Major bleeding	1 year after surgery
Secondary	New dialysis	New dialysis	30 days after surgery
Secondary	New dialysis	New dialysis	1 year after surgery
Secondary	Infection	Infection (including sternal, sepsis, pneumonia)	30 days after surgery
Secondary	Infection	Infection (including sternal, sepsis, pneumonia)	1 year after surgery
Secondary	Re-hospitalization for a vascular reason	Re-hospitalization for a vascular reason	30 days after surgery
Secondary	Re-hospitalization for a vascular reason	Re-hospitalization for a vascular reason	1 year after surgery
Secondary	Chronic incisional pain	Chronic incisional pain	30 days after surgery
Secondary	Chronic incisional pain	Chronic incisional pain	1 year after surgery
Secondary	Frailty	Frailty assessed by PRISMA-7 questionnaire	30 days after surgery
Secondary	Frailty	Frailty assessed by PRISMA-7 questionnaire	1 year after surgery