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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803020
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment
Coronary Artery Disease 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. score of Seattle angina questionnaire [ Time Frame: one year ]
    the result of Seattle angina questionnaire

  2. socre of Self-Rating Anxiety Scale [ Time Frame: one year ]
    result of socre of Self-Rating Anxiety Scale

  3. socre of EuroQol five dimensions questionnaire [ Time Frame: one year ]
    result of EuroQol five dimensions questionnaire

  4. Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up [ Time Frame: one year ]
    Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up

  5. the success rate of Percutaneous Coronary Intervention [ Time Frame: one year ]
    the success rate of Percutaneous Coronary Intervention


Secondary Outcome Measures :
  1. rate of cardiac death rate [ Time Frame: one year ]
    rate of cardiac death rate in one year recorded in follow-up

  2. rate of target vessel revascularization rate [ Time Frame: one year ]
    rate of target vessel revascularization rate in one year recorded in follow-up

  3. rate of recurrent myocardial infarction rate [ Time Frame: one year ]
    rate of recurrent myocardial infarction rate in one year recorded in follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients of single coronary chronic total occlusion
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803020


Contacts
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Contact: Shufu chang, Doctor +8618616881731 chang.shufu@zs-hospital.sh.cn
Contact: Shufu chang, Doctor +18616881731 chang.shufu@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Contact: junbo Ge, Doctor    +86-21-64041990    jbge@zs-hospital.sh.cn   
Contact: jianying Ma, Doctor    +8618616881653    ma.jianying@zs-hospital.sh.cn   
Sub-Investigator: Shufu Chang, doctor         
Sub-Investigator: Rende Xu, doctor         
Sub-Investigator: Qing Qin, doctor         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Jianying Ma, Doctor Department of Cardiology, Zhongshan Hospital
Additional Information:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03803020    
Other Study ID Numbers: SHDC12018X05
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
coronary artery disease
chronic total occlusion
fractional flow reserve
single-photon emission computed tomography
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases