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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03803020
Enrollment
150
Registered
2019-01-14
Start date
2019-01-31
Completion date
2021-12-31
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

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

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.

Interventions

OTHERfractional flow reserve and SPECT detection

fractional flow reserve and SPECT detection

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the success rate of Percutaneous Coronary Interventionone yearthe success rate of Percutaneous Coronary Intervention
socre of Self-Rating Anxiety Scaleone yearresult of socre of Self-Rating Anxiety Scale
socre of EuroQol five dimensions questionnaireone yearresult of EuroQol five dimensions questionnaire
Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-upone yearComposite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
score of Seattle angina questionnaireone yearthe result of Seattle angina questionnaire

Secondary

MeasureTime frameDescription
rate of target vessel revascularization rateone yearrate of target vessel revascularization rate in one year recorded in follow-up
rate of recurrent myocardial infarction rateone yearrate of recurrent myocardial infarction rate in one year recorded in follow-up
rate of cardiac death rateone yearrate of cardiac death rate in one year recorded in follow-up

Countries

China

Contacts

Primary ContactShufu chang, Doctor
chang.shufu@zs-hospital.sh.cn+8618616881731
Backup ContactShufu chang, Doctor
chang.shufu@zs-hospital.sh.cn+18616881731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026