Actively Recruiting
Revascularization Versus Optimal Medical Therapy on Left Ventricular Ischemia Reduction in Chronic Total Coronary Occlusion Patients Exploring Associations Between Ischemia, Functional Outcome, and Collaterals
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-07-20
82
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring whether performing percutaneous coronary intervention (PCI) on patients with chronic total occlusion (CTO) of the coronary artery can reduce ischemia more effectively than optimal medical therapy alone. This study focuses on adults with a significant ischemic burden identified through cardiac imaging. The goal is to understand if PCI leads to better functional outcomes, changes in infarct size, and improved heart function compared to medical treatment without PCI. Participants will be randomly assigned to one of two groups: one receiving PCI with a drug-eluting stent alongside optimal medical therapy, and the other receiving only optimal medical therapy without PCI. The study includes a 6-month follow-up period where the main comparison is the reduction in ischemia measured by exercise myocardial perfusion SPECT-CT scans. Additional evaluations include changes in angina symptoms, quality of life, and heart function using cardiac magnetic resonance imaging. During the study, participants will undergo baseline and 6-month follow-up cardiac imaging to assess ischemia and heart function. Researchers will monitor angina status and quality of life over up to 10 years using questionnaires. Participation involves regular assessments to track the impact of the treatments on heart health and symptoms. Safety and functional outcomes will be closely observed to evaluate the benefits of PCI compared to medical therapy alone.
CONDITIONS
Brief Title
Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A chronic total occlusion with 100% artery blockage, older than 3 months, and suitable for PCI
- Clinical indication to perform CTO PCI
- Baseline SPECT showing ischemia greater than 12.5% in the CTO area with less than 50% infarction extent
- Willingness to undergo follow-up SPECT-CT at 6 months
- Able to understand and provide written informed consent
You will not qualify if you...
- Younger than 18 years old
- Persistent or permanent atrial fibrillation
- Presence of a non-MRI compatible cardiac device such as pacemaker or defibrillator
- Body weight over 250 kg
- Unable to exercise due to physical disability
- Contraindications to SPECT or cardiac MRI, including cerebrovascular clips or claustrophobia
- Known severe kidney problems or on dialysis
- Allergy to contrast agents preventing proper hydration
- Life expectancy less than one year due to other conditions
- Participation in another clinical trial
- Belonging to a vulnerable population or unable to read or write
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive either percutaneous coronary intervention (PCI) with a drug-eluting stent plus optimal medical therapy, or optimal medical therapy alone.
1 baseline visit and multiple follow-up visits over 6 months
Duration - Up to 10 years
Participants are monitored for changes in angina status and quality of life for up to 10 years after treatment.
Scheduled follow-up visits at 6 months, 1 year, and annually up to 10 years
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105AZ
Actively Recruiting
Research Team
P
Prof. J.P.S. Henriques, MD PhD
M
Ms. A. van Veelen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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