Coronary Artery Disease Clinical Trial
Official title:
Coronary CT Angiography-Derived Fractional Flow Reserve-guided Optimize Treatment Strategy for In-stent Restenosis
This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis.
Status | Not yet recruiting |
Enrollment | 294 |
Est. completion date | December 11, 2025 |
Est. primary completion date | December 11, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - (1) >18 years old; - (2) ability to provide informed consent; - (3) previous PCI who underwent CCTA and have at least 1 lesion with a percent diameter in-stent stenosis between 30% and 90% in a coronary artery with a =2.25 mm reference vessel diameter by visual assessment; - (4) accepted further clinically indicated coronary testing, coronary arteriography, or FFR, or IVUS, or PCI, etc. Exclusion Criteria: - (1) Prior coronary artery bypass surgery (CABG), heart valve surgery, cardiac pacemaker, or implanted cardiac defibrillator; - (2) Target vascular stents were evaluated for implantation within one month; - (3) unstable clinical conditions including acute chest pain, cardiogenic shock, congestive heart failure (NYHA grade III or IV), unstable blood pressure (systolic blood pressure < 90mmHg) or acute pulmonary edema; - (4) Acute myocardial infarction occurred within 7 days before enrollment, and left ventricular ejection fraction =40%; - (5) Other severe cases are not suitable for clinical trials including complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and severe chronic renal damage; - (6) Contraindication to beta blockers, nitroglycerin, adenosine, or allergy to iodine contrast agents; - (7) Pregnancy or pregnancy status unknown; - (8) Life expectancy <1 years; - (9)Repeated enrollment; - (10) Any other factors that other researchers consider not suitable for inclusion or completion of this study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Yan'an Affiliated Hospital of Kunming Medical University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 12-month MACE | 12-month Major Adverse Coronary Event (MACE) rates, defined as:
All cause death Non-fatal myocardial infarction (MI) Ischemia-driven target vessel revascularization (TVR) |
12 months | |
Secondary | MACE | MACE defined as:
All cause death Non-fatal MI Clinical-driven TVR |
3-month, 6-month, 24-month, 36-month | |
Secondary | Rates of Target lesion failure (TLF) | Composite of clinically driven TLR, MI or cardiac death related to the target vessel. | 3-month, 6-month, 24-month, 36-month | |
Secondary | Total costs | Total costs will be calculated from the use of all cardiac-related invasive and non-invasive tests, revascularization procedures, hospital admissions and outpatient attendances due to a cardiovascular cause, and cardiac medications. | 6-month, 12-month | |
Secondary | Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire | Quality of life (QOL), will be assessed using the EQ-5D-VAS questionnaire | 6-month, 12-month | |
Secondary | Seattle Angina Questionnaire | angina status, will be assessed using the Seattle Angina Questionnaire | 6-month, 12-month | |
Secondary | Cumulative radiation exposure | Cumulative radiation exposure within 6-month and 12-month of study entry included all cardiovascular tests and invasive procedures, including CTA, myocardial perfusion imaging, and ICA. | 6-month, 12-month |
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