Influence of Risk Factors on ISR and Nonintervened Lesions

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Multi Vessel Coronary Artery Disease Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, 200127, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

LDL-C, mmol/L

Time frame: 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 outcomes

HbA1c, %

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Influence of Risk Factors Such as Serum Cholesterol Level on ISR and Nonintervened Coronary Lesions

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Sep 15, 2023
Registry last updated: Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed