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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
A percutaneous coronary intervention of the chronic total occlusion with a drug-eluting stent.
Amsterdam UMC, location AMC
Amsterdam, Netherlands
RECRUITINGIschemia
Ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.
Time frame: 6 months follow-up
Change in angina status assessed with the Seattle Angina Questionnaire.
5 Seattle Angina Questionnaire subscales (0-100), higher scores indicating better angina status.
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Quality of life assessed with the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
MLHFQ scale (0-105), lower scores indicating better quality of life.
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
The left ventricular ejection fraction assessed with cardiac magnetic resonance imaging
Time frame: 6 months
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