Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03756870

Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-07-20

82

Participants Needed

1

Research Sites

548 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Rationale: Randomized trials could not yet establish favourable outcomes of CTO PCI on hard endpoints such as ejection fraction or mortality, when compared to optimal medical therapy. However, patients after CTO PCI appeared to be more frequently free of angina complaints, but the aetiology behind this is not fully understood. The investigators hypothesize that PCI of the CTO in patients preselected with an ischemic threshold (\>12.5%) on cardiac imaging leads to a reduction of the ischemic burden and therefore an increased benefit on functional outcomes. Objective: Primary objective is to determine whether PCI of the CTO will yield a higher reduction of ischemia assessed by exercise myocardial perfusion SPECT-CT from baseline to 6-month follow-up compared to a control group. Secondary objectives are 1) to evaluate the effect of PCI of the CTO on improvement in functional status, infarct size and left ventricular function from baseline to follow-up compared to the control group; 2) to study the association between ischemia reduction and functional outcome and left ventricular function; 3) to assess the influence of the collateral flow index on the ischemic burden (reduction), functional status, infarct size and left ventricular (contractile) function (hibernation). Study design: open multicentre randomized trial Study population: 82 patients eligible for CTO PCI Intervention: CTO PCI Primary endpoint: ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.

CONDITIONS

Official Title

Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of a chronic total occlusion (CTO) with 100% artery blockage and no forward blood flow
  • CTO has been present for more than 3 months confirmed by previous PCI or angiography
  • CTO is suitable for percutaneous revascularization
  • Clinical indication to perform CTO PCI
  • Baseline SPECT shows ischemia greater than 12.5% with less than 50% infarction in the affected area
  • Baseline cardiac magnetic resonance imaging (CMR) performed to assess heart tissue viability
  • Willingness to undergo follow-up SPECT-CT imaging at 6 months
  • Able to provide written informed consent and understand study procedures
Not Eligible

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 implantable cardioverter defibrillator
  • Body weight over 250 kg
  • Unable to perform exercise due to physical disability
  • Contraindications for SPECT or CMR imaging like cerebrovascular clips or claustrophobia
  • Known kidney problems with estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2, serum creatinine above 2.5 mg/dL, or on dialysis
  • Allergy or hypersensitivity to contrast agents that cannot be managed by pre-hydration
  • Any serious illness with life expectancy less than one year
  • Participation in another clinical trial
  • Belonging to a vulnerable population or unable to read or write as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC, location AMC

Amsterdam, Netherlands, 1105AZ

Actively Recruiting

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Research Team

P

Prof. J.P.S. Henriques, MD PhD

CONTACT

M

Ms. A. van Veelen, MD

CONTACT

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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