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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03803020
• Other study ID #: SHDC12018X05
• Status: Not yet recruiting
• Start date: January 2019
• Est. completion date: December 2021

Study information

• Verified date: January 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Shufu chang, Doctor
• Phone: +8618616881731
• Email: chang.shufu[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• fractional flow reserve and SPECT detection
fractional flow reserve and SPECT detection

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score of Seattle angina questionnaire	the result of Seattle angina questionnaire	one year
Primary	socre of Self-Rating Anxiety Scale	result of socre of Self-Rating Anxiety Scale	one year
Primary	socre of EuroQol five dimensions questionnaire	result of EuroQol five dimensions questionnaire	one year
Primary	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
Primary	the success rate of Percutaneous Coronary Intervention	the success rate of Percutaneous Coronary Intervention	one year
Secondary	rate of cardiac death rate	rate of cardiac death rate in one year recorded in follow-up	one year
Secondary	rate of target vessel revascularization rate	rate of target vessel revascularization rate in one year recorded in follow-up	one year
Secondary	rate of recurrent myocardial infarction rate	rate of recurrent myocardial infarction rate in one year recorded in follow-up	one year