Actively Recruiting

Age: 18Years - 90Years
All Genders
ID04772768

Patients With Prior Coronary Artery Bypass Graft Surgery Evaluated for Saphenous Vein Graft Dysfunction and Progression of Coronary Artery Disease

Led by Amsterdam UMC, location VUmc · Updated on 2023-06-02

500

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study patients who have had coronary artery bypass grafting (CABG) surgery and have at least one saphenous vein graft (SVG), especially those experiencing recurrent ischemic symptoms. The goal is to understand clinical outcomes related to graft failure and progression of native coronary artery disease (CAD). This observational study focuses on patients often older with complex heart conditions who are evaluated for these issues, as current treatment guidelines are limited for this group. Participants will be observed without intervention, with data collected from national registries, electronic medical records, and standardized phone assessments at 3 and 5 years after enrollment. Diagnostic results from non-invasive and invasive tests, such as graft patency and heart function assessments, will be gathered to evaluate their usefulness in guiding repeat revascularization treatments. During the study, participants will undergo regular follow-up assessments at 3 and 5 years to monitor major cardiovascular events and graft status. Quality of life will be measured using specific heart-related questionnaires. Researchers will also track procedural success and mortality for patients who undergo further interventions. The total observation period includes ongoing data collection through medical records and patient contact to better understand long-term outcomes after CABG.

CONDITIONS

Brief Title

Prior CABG Patients Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Prior coronary artery bypass grafting
  • One or more saphenous vein grafts
  • Recurrent angina symptoms
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Age 90 years or older
  • Cardiogenic shock
  • Pregnancy
  • Failure to provide informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At the time of referral

Participants undergo clinical evaluation and diagnostic work-up to assess saphenous vein graft patency, native coronary artery disease progression, left ventricular function, and myocardial viability.

1 visit (in-person)

Long-term Monitoring

Duration - 3 to 5 years

Participants are observed over several years to track clinical outcomes including major adverse cardiovascular events and graft failure, with assessments of quality of life.

Follow-up visits at baseline and during 3 and 5 years

Trial Site Locations

Total: 1 location

1

Amsterdam University Medical Centers, Department of Cardiology

Amsterdam, Netherlands, 1081 HV

Actively Recruiting

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Research Team

P

Paul Knaapen, Professor

R

Ruben de Winter, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial