1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response (Others) - 


6. For how long will this data be available start date provided 02-07-2026 and end date provided 02-11-2031?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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.