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临床试验/CTRI/2025/10/095535
CTRI/2025/10/095535尚未招募不适用

Effect of nurse-led lifestyle modification program on short term clinical outcomes in patients with higher SYNTAX score undergoing PCI: A quasi experimental study.

NOT APPLICABLE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Primary CLINICAL OUTCOMES

研究概览

简要总结

Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide, contributing to approximately 17.9 million deaths annually, with nearly 85 percent due to heart attacks and strokes. The burden is particularly high in low and middle income countries due to disparities in healthcare access, lifestyle related risk factors, and socioeconomic conditions. Coronary artery disease (CAD), a major type of CVD, occurs when fatty deposits build up in the coronary arteries, restricting blood flow and increasing the risk of heart attacks. Percutaneous coronary intervention (PCI) is a common minimally invasive procedure used to treat CAD, usually through balloon angioplasty or stent placement, but complications such as restenosis, recurrent myocardial infarction, and need for repeat procedures remain. The SYNTAX score is a widely used tool to assess CAD complexity and guide revascularization strategies.

In India, the prevalence of CVD is rising in both urban and rural areas. Patients with higher SYNTAX scores (22 or above) have more complex CAD and face increased risks of adverse events post PCI, including cardiogenic shock, cardiac arrest, stroke, and restenosis. Hematological indices such as neutrophil to lymphocyte ratio, monocyte to lymphocyte ratio, platelet to lymphocyte ratio, systemic immune inflammation index, and systemic inflammation response index have been identified as cost effective prognostic markers for major adverse cardiac events after PCI. Secondary prevention, including adherence to medical therapy and lifestyle modifications like diet, physical activity, smoking cessation, stress management, and medication adherence, reduces complications and improves outcomes. However, patients often face challenges in sustaining these practices without proper guidance. Nurse led lifestyle modification programs have shown effectiveness in improving adherence and recovery, but there is limited evidence regarding their role in patients with higher SYNTAX scores undergoing PCI.

The present study aims to evaluate the effect of a nurse led lifestyle modification program on short term clinical outcomes in patients with higher SYNTAX scores undergoing PCI. The intervention includes individualized health education on diet, exercise, smoking cessation, stress management, and medication adherence, along with distribution of an educational booklet and weekly telephonic follow ups for one month. Short term clinical outcomes will include the occurrence of major adverse cardiac events, changes in novel hematological indices, and secondary outcomes such as ejection fraction and blood pressure, measured after one month of PCI. A higher SYNTAX score will be defined as 22 or above.

The study objectives are to assess and compare short term clinical outcomes in the experimental and control groups, and to examine associations between selected demographic and clinical variables with short term outcomes. The hypotheses to be tested at the 0.05 level of significance are: (H01) there will be no significant difference in short term clinical outcomes between the experimental and control groups, and (H02) there will be no significant association between selected demographic and clinical variables and short term outcomes in both groups.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Participants included in the study will be those who have undergone percutaneous coronary intervention (PCI) and are willing to participate, are above 18 years of age, can understand either Hindi or English, are accessible via telephone, and have a SYNTAX score of 22 or higher.

排除标准

  • Patient who needs emergency cardiac surgery post PCI.
  • Patient who are admitted for MACE and going for PCI.

结局指标

主要结局

Primary CLINICAL OUTCOMES

时间窗: Every week for 1 month

PART-1: MACE check list

时间窗: Every week for 1 month

Myocardial infarction (MI), stroke/cerebrovascular event, hospital readmission, revascularization, cardiovascular death and mortality (all-cause)

时间窗: Every week for 1 month

PART-2: Novel haematological indices

时间窗: Every week for 1 month

Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), monocyte-to-HDL ratio (MHR), high-sensitivity C-reactive protein (hs-CRP), NT-Pro (BNP), and the triglyceride-glucose (TyG) Index.

时间窗: Every week for 1 month

次要结局

  • Secondary outcomes(Ejection fraction & blood pressure)

研究者

申办方类型
Other [Not applicable]
责任方
Principal Investigator
主要研究者

Vandana Devi

AIIMS,Jodhpur

研究点 (1)

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