Clinical trial NCT06039059: Influence of Risk Factors on ISR and Nonintervened Lesions
Official title: Influence of Risk Factors Such as Serum Cholesterol Level on ISR and Nonintervened Coronary Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Multi Vessel Coronary Artery Disease
Keywords: ISR, nonintervened coronary lesions, risk factor
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 510
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multivessel lesions that had treated part of the vessels.

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.


Eligibility criteria: 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

Primary outcomes:
measure: LDL-C, mmol/L
timeFrame: Blood samples were collected after a 12-hour fast before CAG.
Secondary outcomes:
measure: HbA1c, %
timeFrame: Blood samples were collected after a 12-hour fast before CAG.
measure: ALT, U/L
timeFrame: Blood samples were collected after a 12-hour fast before CAG.
measure: Scr, mmol/L
timeFrame: Blood samples were collected after a 12-hour fast before CAG.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References:
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