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

NCT03803020 | Unknown

• 1 other identifier: SHDC12018X05
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; chronic total occlusion; fractional flow reserve; single-photon emission computed tomography

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• rate of cardiac death rate

  one year

• rate of target vessel revascularization rate

  one year

• rate of recurrent myocardial infarction rate

  one year

Study Arms (1)

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

Interventions

fractional flow reserve and SPECT detection OTHER

fractional flow reserve and SPECT detection

single coronary chronic total occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients of single coronary chronic total occlusion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jianying Ma, Doctor

  Department of Cardiology, Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shufu chang, Doctor

CONTACT

+8618616881731; chang.shufu@zs-hospital.sh.cn

Shufu chang, Doctor

CONTACT

+18616881731; chang.shufu@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 14, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)