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| Name | Class |
|---|---|
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Beijing Friendship Hospital | OTHER |
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The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on cardiac function in multi-vessel disease patients with concurrent chronic total occlusion (CTO) lesion.
Recruited CTO patients will be devided into two groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group). The primary outcome assessed will be the change in cardiac function evaluated via CMR at a 12-month of follow-up appointment, which will be compared to a baseline measurement. Secondary outcomes include occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 after 12-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete revascularization group | Complete Revascularization of CTO and non-CTO lesions |
| |
| Non-CTO revascularization group | Non-CTO vessel revascularization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor | Drug | Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of left ventricular ejection fraction (LVEF) | Changes of LVEF, LVEDV, and LVESV assessed with the use of cardiac MRI. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | all-cause mortality, cardiac death, a first or recurrent, non-fatal, acute myocardial infarction, target lesion revascularization (PCI or CABG), stroke, heart failure and cardiac rehospitalization | 1, 6, and 12 months post-PCI |
| Myocardial viability |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints | The safety of the perioperative period, including acute coronary artery occlusion, acute vascular perforation, acute stent thrombosis, acute myocardial infarction, and cardiac death | perioperative period |
Inclusion criteria:
Patients should be 18-80 years old; be diagnosed with single CTO concurrent with MVD detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis); present with an LVEF above 35% determined using transthoracic echocardiography; present with CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm; and comply all the evaluations and follow-up protocols.
Exclusion criteria:
Patients will be excluded if they have suffered from acute myocardial infarction within the previous 3 months; a lesion located in the left main artery (stenosis ≥50%); rheumatic valvular disease; severe arrhythmia; a history of revascularization within the non-CTO artery; multiple vessels with CTO (more than one CTO artery); lesions unsuitable for PCI; severely abnormal hematopoietic systems, such as platelet counts <100 x 109/L or > 700 x 109/L and white blood cell counts < 3 x 109/L; with active bleeding or bleeding tendencies (active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency); severe coexisting conditions, including severe renal function dysfunction [Glomerular filtration rate (GFR) less than 60 ml/min • 1.73 m2), severe hepatic dysfunction [glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders; tumors; surgery within 3 months; a life expectancy less than 12 months; pregnancy or planning to become pregnant; history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents. Patients will also be excluded if they cannot tolerate dual antiplatelet treatment (DAPT); are unable to communicate due to cognitive impairment, auditory, or visual impairment; are participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention.](streamdown:incomplete-link)
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Patients should be 18-80 years old; be diagnosed with single CTO concurrent with MVD detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis); present with an LVEF above 35% determined using transthoracic echocardiography; present with CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm; and comply all the evaluations and follow-up protocols
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| Name | Affiliation | Role |
|---|---|---|
| Xiantao Song, MD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University | Beijing | China |
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|
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| coronary wires. stents or coronary balloons | Device | all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA) |
|
|
myocardial viability in the territory supplied by the CTO artery |
| 12 months post-PCI |
| Quality of life changes | Seattle Angina Questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 | 1, 6, and 12-month follow-up |
| Contrast used | contrast used | during the procedure |
| Total cost of medical care | total cost of medical care covering optimal medicine therapy and the equipment for coronary artery disease therapy from the day of enrollment (first hospitalization) to the last follow-up (rehospitalization) | from the day of enrollment (first hospitalization) to the last follow-up (rehospitalization) |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D008790 | Metoprolol |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| D000077144 | Clopidogrel |
| D000077486 | Ticagrelor |
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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