Procedure: Multiple arterial grafting for Coronary Artery Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Coronary Artery Disease+2 More
Procedure: Multiple arterial grafting - Procedure
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will compare the outcomes of women who receive one arterial graft during CABG surgery (SAG) to those who receive multiple arterial grafts (MAG).

Eligible Conditions
  • Coronary Artery Disease
  • Coronary Artery Bypass Surgery
  • Heart Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 18 Secondary · Reporting Duration: > 48 hours postoperatively, minimum 2.5 year follow-up

Year 12
Cause-specific death (cardiac vs non-cardiac)
Major post-operative complications such as bleeding, stroke, surgical site complication
Sternal wound complications
Stroke, post discharge myocardial infarction and repeat revascularization considered as individual events
Year 12
Hospital readmissions with specific causes
30-day mortality
Mortality
Year 5
Myocardial Infarction
Hour 72
Death from any cause, any stroke, myocardial infarction
Year 5
Death from any cause
Cerebral Revascularization
Cerebral Revascularization
Generic quality of life according to EuroQuol-5D (EQ-5D)
Generic quality of life according to the Short Form Health Survey (SF-12v2)
Generic quality of life, mental and physical health symptoms
Mental and physical health symptoms according to PROMIS instruments
Acute Coronary Syndrome
Heart failure
Repeat revascularization
Cerebrovascular accident
Cerebral Revascularization
Disease
Day 30
Other recorded outcomes (safety endpoints)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Multiple Arterial Graft (MAG) group
1 of 4
Single Arterial Graft (SAG) group
1 of 4
Single Arterial Group
1 of 4
Multiple Arterial Group
1 of 4

Experimental Treatment

2000 Total Participants · 4 Treatment Groups

Primary Treatment: Procedure: Multiple arterial grafting · No Placebo Group · N/A

Multiple Arterial Graft (MAG) group
Procedure
Experimental Group · 1 Intervention: Multiple arterial grafting · Intervention Types: Procedure
Single Arterial Graft (SAG) group
Procedure
Experimental Group · 1 Intervention: Single arterial graft · Intervention Types: Procedure
Single Arterial Group
Procedure
Experimental Group · 1 Intervention: Procedure: Single arterial graft · Intervention Types: Procedure
Multiple Arterial Group
Procedure
Experimental Group · 1 Intervention: Procedure: Multiple arterial grafting · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: > 48 hours postoperatively, minimum 2.5 year follow-up

Who is running the clinical trial?

Oxford University Hospitals NHS TrustOTHER
194 Previous Clinical Trials
2,013,687 Total Patients Enrolled
5 Trials studying Coronary Artery Disease
23,876 Patients Enrolled for Coronary Artery Disease
University of GöttingenOTHER
62 Previous Clinical Trials
28,852 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
1,121 Patients Enrolled for Coronary Artery Disease
Maastricht University Medical CenterLead Sponsor
853 Previous Clinical Trials
3,535,217 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
11,565 Patients Enrolled for Coronary Artery Disease
Columbia UniversityOTHER
1,284 Previous Clinical Trials
1,611,524 Total Patients Enrolled
12 Trials studying Coronary Artery Disease
12,514 Patients Enrolled for Coronary Artery Disease
New York Presbyterian HospitalOTHER
70 Previous Clinical Trials
28,141 Total Patients Enrolled
Cedars-Sinai Medical CenterOTHER
452 Previous Clinical Trials
142,172 Total Patients Enrolled
22 Trials studying Coronary Artery Disease
15,623 Patients Enrolled for Coronary Artery Disease
Sunnybrook Health Sciences CentreOTHER
599 Previous Clinical Trials
1,466,416 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
2,197 Patients Enrolled for Coronary Artery Disease
Weill Medical College of Cornell UniversityLead Sponsor
983 Previous Clinical Trials
1,336,452 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
41,993 Patients Enrolled for Coronary Artery Disease
Duke UniversityOTHER
2,159 Previous Clinical Trials
3,186,578 Total Patients Enrolled
16 Trials studying Coronary Artery Disease
48,117 Patients Enrolled for Coronary Artery Disease
Roberto Lorusso, Prof/PhD/MDPrincipal InvestigatorMaastricht University Medical Centre, Maastricht, The Netherlands
David Taggart, Prof/PhD/MDPrincipal InvestigatorJohn Radcliffe Hospital, Oxford, United Kingdom
Ingo Kutschka, Prof/PhD/MDPrincipal InvestigatorUniversitätsmedizin Göttingen, Göttingen Germany
Mario Gaudino, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
4,300 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
4,300 Patients Enrolled for Coronary Artery Disease
Mario Gaudino, Prof/PhD/MDPrincipal InvestigatorWeill Medical College of Cornell University
Ruth Masterson Creber, RN, PhDPrincipal InvestigatorColumbia University
C. Noel Bairey Merz, MDPrincipal InvestigatorCedars-Sinai
8 Previous Clinical Trials
1,148 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
179 Patients Enrolled for Coronary Artery Disease
Karla Ballman, PhDPrincipal InvestigatorWeill Medical College of Cornell University
Stephen Fremes, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
3 Previous Clinical Trials
4,565 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
4,565 Patients Enrolled for Coronary Artery Disease
Sean O'Brien, PhDPrincipal InvestigatorDuke University

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References