coronary atherosclerotic heart disease
Conditions
Interventions
Intervention group:Colchicine treatment
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Preoperative admission criteria: 1. Aged >= 18 years; 2. At least one of the following conditions is met: (1) Coronary CTA suggested that coronary artery stenosis or occlusion of moderate degree or above, and calcification score CACS >= 101; (2) Angina pectoris is diagnosed and there is evidence of severe calcification in other arteries outside the coronary artery, such as carotid artery and lower limb artery; (3) One of the following conditions exists during previous coronary angiography (see patient screening evaluation criteria for details): 1) Before injection of contrast agent, there were obvious opaque images in the diseased vessels, especially on both sides of the vessels; 2) The target vessel had undergone balloon dilation, but there was poor balloon dilation (residual lumbar sign); 3) IVUS examination indicated that the calcification ring spaned 3-4 quadrants, >= 270 degree; 4) IVUS examination suggested calcified nodules that might cause poor stent expansion and adhesion; 5) OCT examination indicated that the radian of the calcified plaque was > 180 degree and the thickness was > 0.5 mm and the length of the calcified plaque > 5 mm; 6) Previous attempts at revascularization of the target vessel failed due to calcification; Intraoperative inclusion criteria (meeting one of the following criteria) : 1. IVUS examination suggests that the calcification ring spans 3-4 quadrants, >= 270 degree; 2. IVUS examination suggests calcified nodules that might cause poor stent expansion and adhesion; 3. OCT examination indicates that the radian of calcified plaque is > 180 degree, the thickness is > 0.5 mm and the length is > 5 mm in calcified area; 4. The diameter of the distal normal segment of the target vessel is 2.5 mm or more; 5. Poor distention with predilated balloon expansion (residual lumbar sign); 6. Due to severe calcification, intraluminal imaging devices or predilated balloons cannot pass through the lesion site; 7. Other conditions that the surgeon considers to require coronary rotary grinding.
Exclusion criteria
Exclusion criteria: Preoperative exclusion criteria: 1. Cardiogenic shock or hemodynamic instability; 2. Patients with myocardial infarction; 3. Uncontrolled ejection fraction reduces heart failure; 4. Severe hepatic or renal dysfunction (glomerular filtration rate < 30 mL/min or at dialysis); 5. Chronic inflammation; 6. Autoimmune diseases; 7. Malignant diseases; 8. Pregnant or lactating women; 9. Patients with known colchicine hypersensitivity or who have taken colchicine; 10. Patients who cannot tolerate coronary angiography and perioperative and postoperative medication; Intraoperative exclusion criteria: 1. In addition to the rotational artherectomy related vessels, there are other vascular lesions that required revascularization; 2. Intracavitary imaging evaluation without rotational artherectomy; 3. The balloon can fully pre-expand the target lesion, the balloon is well expanded, the stent is well expanded, and there is no need for rotational artherectomy; 4. Intraoperative contraindications of rotational artherectomy: thrombotic lesions, c-type or above vascular dissection, severe vascular tortuan angulation, CTO lesions in which the guidewire is not completely in the true lumen of the vessel, etc.; 5. Other circumstances in which the operator considers that rotational artherectomy is not necessary or cannot be performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cTnI; | — |
Secondary
| Measure | Time frame |
|---|---|
| caIMR;caFFR;Tissue Doppler echocardiography;Postoperation incidence rate of slow flow and no reflow phenomenon;NETs;Platelet activation marker;Cardiovascular events after 6 months postoperation; | — |
Countries
China
Contacts
Public ContactYang Qing
Tianjin Medical University General Hospital
Outcome results
None listed