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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03803020
Other study ID # SHDC12018X05
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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