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Clinical Trials/CTRI/2025/10/095535
CTRI/2025/10/095535
Not yet recruiting
Not Applicable

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 site in 1 country60 target enrollmentStarted: October 24, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Primary CLINICAL OUTCOMES

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Primary CLINICAL OUTCOMES

Time Frame: Every week for 1 month

PART-1: MACE check list

Time Frame: Every week for 1 month

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

Time Frame: Every week for 1 month

PART-2: Novel haematological indices

Time Frame: 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.

Time Frame: Every week for 1 month

Secondary Outcomes

  • Secondary outcomes(Ejection fraction & blood pressure)

Investigators

Sponsor Class
Other [Not applicable]
Responsible Party
Principal Investigator
Principal Investigator

Vandana Devi

AIIMS,Jodhpur

Study Sites (1)

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