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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: fractional flow reserve and SPECT detection

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients of single coronary chronic total occlusion

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
single coronary chronic total occlusion; 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; fractional flow reserve and SPECT detection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Jianying Ma, Doctor, Department of Cardiology, Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: coronary artery disease; chronic total occlusion; fractional flow reserve; single-photon emission computed tomography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: SHDC12018X05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No