The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion

Study Overview
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Brief Summary
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Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.

Detailed Description
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Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.

Official Title
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The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: fractional flow reserve and SPECT detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years old single CTO lesions, or other stenosis have been PCI treated for more than one months the diameter of target vessel ≥2.5mm stable angina pectoris, or myocardial ischemia in the area of CTO lesions the patients agree to this research plan and sign the consent form, and complete the follow-up Exclusion Criteria: Acute myocardial infarction in one month In addition to the area of CTO lesions, there are serious untreated coronary lesions bridge vascular CTO lesions untreated coronary artery or cardiac surgery due to interventional complications, or intraoperative death acute decompensated heart failure allergies to contrast or radionuclide tracers patients with planned pregnancies or lactation or 1 years after intervention malignant neoplasms or life expectancy of less than 1 years patients plan of surgery patients cannot tolerate double antiplatelet therapy for at least 12 months any condition that does not fit coronary intervention or is a drug-eluting stent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single coronary chronic total occlusion<br>symptomatic stable angina of single coronary chronic total occlusion without other coronary artery stenosis scheduled for elective PCI. fractional flow reserve and SPECT detection before and after intervention. | Other: fractional flow reserve and SPECT detection<br>* fractional flow reserve and SPECT detection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of Seattle angina questionnaire | the result of Seattle angina questionnaire | one year | 
| socre of Self-Rating Anxiety Scale | result of socre of Self-Rating Anxiety Scale | one year | 
| socre of EuroQol five dimensions questionnaire | result of EuroQol five dimensions questionnaire | one year | 
| Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up | Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up | one year | 
| the success rate of Percutaneous Coronary Intervention | the success rate of Percutaneous Coronary Intervention | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of cardiac death rate | rate of cardiac death rate in one year recorded in follow-up | one year | 
| rate of target vessel revascularization rate | rate of target vessel revascularization rate in one year recorded in follow-up | one year | 
| rate of recurrent myocardial infarction rate | rate of recurrent myocardial infarction rate in one year recorded in follow-up | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, chronic total occlusion, fractional flow reserve, single-photon emission computed tomography