Clinical trial NCT03803020: The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion
Official title: The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
chronic total occlusion
fractional flow reserve
single-photon emission computed tomography
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of single coronary chronic total occlusion

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: score of Seattle angina questionnaire
timeFrame: one year
measure: socre of Self-Rating Anxiety Scale
timeFrame: one year
measure: socre of EuroQol five dimensions questionnaire
timeFrame: one year
measure: Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
timeFrame: one year
measure: the success rate of Percutaneous Coronary Intervention
timeFrame: one year
Secondary outcomes:
measure: rate of cardiac death rate
timeFrame: one year
measure: rate of target vessel revascularization rate
timeFrame: one year
measure: rate of recurrent myocardial infarction rate
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Zhongshan Hospital
name: Jianying Ma, Doctor
role: PRINCIPAL_INVESTIGATOR
References: