Influence of Risk Factors on ISR and Nonintervened Lesions

September 13, 2023 updated by: RenJi Hospital

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200127
        • Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with multivessel lesions that had treated part of the vessels.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Receiving PCI with nonintervened coronary lesion
Patients who received PCI with nonintervened coronary lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Blood samples were collected after a 12-hour fast before CAG.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Blood samples were collected after a 12-hour fast before CAG.
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.
Blood samples were collected after a 12-hour fast before CAG.
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.
Blood samples were collected after a 12-hour fast before CAG.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rf on ISR and nonintervented

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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