Coronary Artery DiseaseNCT03803020
The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- fractional flow reserve and SPECT detection
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2019to Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of single coronary chronic total occlusion
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
junbo Ge, Doctor, +86-21-64041990, jbge@zs-hospital.sh.cn
jianying Ma, Doctor, +8618616881653, ma.jianying@zs-hospital.sh.cn
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- fractional flow reserve and SPECT detection
- Keywords
- coronary artery disease, chronic total occlusion, fractional flow reserve, single-photon emission computed tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional flow reserve and SPECT detectionOther
fractional flow reserve and SPECT detection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: fractional flow reserve and SPECT detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of Seattle angina questionnaire
the result of Seattle angina questionnaire
Measured: one year
socre of Self-Rating Anxiety Scale
result of socre of Self-Rating Anxiety Scale
Measured: one year
socre of EuroQol five dimensions questionnaire
result of EuroQol five dimensions questionnaire
Measured: 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
Measured: one year
the success rate of Percutaneous Coronary Intervention
the success rate of Percutaneous Coronary Intervention
Measured: one year
Secondary outcomes (3)
rate of cardiac death rate
rate of cardiac death rate in one year recorded in follow-up
Measured: one year
rate of target vessel revascularization rate
rate of target vessel revascularization rate in one year recorded in follow-up
Measured: one year
rate of recurrent myocardial infarction rate
rate of recurrent myocardial infarction rate in one year recorded in follow-up
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianying Ma, Doctor, Principal investigator, Department of Cardiology, Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803020
- Sponsor's protocol ID
- SHDC12018X05
- Status last verified
- Jan 2019
- First submitted
- 28 Dec 2018
- Last updated
- 14 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT03803020
- Acronym / sponsor ID
- SHDC12018X05
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, chronic total occlusion, fractional flow reserve, single-photon emission computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single coronary chronic total occlusion | – | Other: fractional flow reserve and SPECT detectionsymptomatic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of single coronary chronic total occlusion
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractional flow reserve and SPECT detectionfractional flow reserve and SPECT detection | Other | single coronary chronic total occlusion |
Primary outcome
score of Seattle angina questionnaire
Time frame: one year
the result of Seattle angina questionnaire
socre of Self-Rating Anxiety Scale
Time frame: one year
result of socre of Self-Rating Anxiety Scale
socre of EuroQol five dimensions questionnaire
Time frame: one year
result of EuroQol five dimensions questionnaire
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
the success rate of Percutaneous Coronary Intervention
Time frame: one year
the success rate of Percutaneous Coronary Intervention
3 secondary outcomes
rate of cardiac death rate
Time frame: one year
rate of target vessel revascularization rate
Time frame: one year
rate of recurrent myocardial infarction rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianying Ma, Doctor principal investigator
Department of Cardiology, Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shufu chang, Doctor (+8618616881731, chang.shufu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of Seattle angina questionnaire (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.