Influence of Risk Factors on ISR and Nonintervened Lesions

Completed

• Conditions: Coronary Artery Disease; Multi Vessel Coronary Artery Disease

• Registration Number: NCT06039059
• Lead Sponsor: RenJi Hospital

Brief Summary

This study enrolled patients who used to received PCI therapy with nonintervened coronary lesions. Baseline characteristics and laboratory testing were collected to find out the risk factor difference between ISR and nonintervened coronary lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31
• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

• (1) PCI therapy with drug-coated stents was performed in the past, and nonintervened coronary lesion remained except in the target vessel.

  (2) CAG was performed again due to re-examination, recurrent angina symptoms, positive treadmill exercise test or coronary CTA showing moderate to severe vessel diameter stenosis.

  (3) Long-term regular oral administration of statins and lipid monitoring were conducted after PCI.

Exclusion Criteria

• Patients with a history of CABG, renal replacement therapy, autoimmune disease, and malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LDL-C, mmol/L	Blood samples were collected after a 12-hour fast before CAG.	Low-density cholesterol (LDL-C) is the cholesterol in low-density lipoprotein (LDL), which reflects how much LDL is present.

Secondary Outcome Measures

Name	Time	Method
HbA1c, %	Blood samples were collected after a 12-hour fast before CAG.	Hemoglobin a1c (HbA1c) is the combination of hemoglobin and blood sugar. Its concentration in the blood is stable and is not affected by short-term blood sugar concentrations. Hemoglobin A1C has obvious clinical value in the diagnosis of diabetes.
ALT, U/L	Blood samples were collected after a 12-hour fast before CAG.	Alanine aminotransferase (ALT) mainly exists in the plasma of liver cells, and the intracellular concentration is 1000-3000 times higher than that in serum. As long as 1% of liver cells are destroyed, it can double the serum enzyme. Therefore, alanine transaminase is recommended by the World Health Organization as the most sensitive detection index of liver function damage.
Scr, mmol/L	Blood samples were collected after a 12-hour fast before CAG.	Serum creatinine (Scr) is a compound produced in muscles during the production of energy. Healthy kidneys filter creatinine from the blood. Creatinine is excreted in the urine as a metabolite and is a common measure of the kidney's filtration function. Creatinine this indicator belongs to the blood biochemical test, the higher the creatinine level, usually indicates the worse the kidney function.

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China