Research Protocol

The clinical profile, management, and outcome of young patients presenting with the acute coronary syndrome at a tertiary care health facility

S. Aravindakumar¹, Annup Balan²,*, Venkita S Suresh³

¹Chief Consultant Interventional Cardiologist, Kauvery Hospital, Heart City-Trichy, India

²Associate Consultant, HIC & Microbiology, Kauvery Hospitals, India

³Group Medical Director, Kauvery Hospitals, India

Background

Coronary Artery Disease (CAD) is the single most cause of mortality and loss of Disability Adjusted Life Years (DALY) globally. A large number of the global burden is limited to the Low and Middle-income countries (LMIC). Twenty-five percent of all deaths in India are attributable to Cardiovascular Diseases (CVD).

CAD results due to the presence of atherosclerosis in the coronary arteries. Coronary Heart Disease (CHD)/Ischemic Heart Disease (IHD) includes the diagnosis of Stable Angina, Acute Coronary Syndrome (ACS), and silent myocardial ischemia. ACS often presents with a symptom and includes unstable angina and myocardial infarction (MI). The survivors of MI are generally at a higher risk for recurrent infarction and a six-fold risk of annual mortality when compared to matched normal individuals.

CAD occurs at a younger age in Indians. The general onset of CAD among Indians was by at least a decade earlier when compared to the Western Population. Although Young patients with CAD have a relatively good prognosis, they carry substantial morbidity, psychological impact, financial burden with significant loss of DALY.

The most common reasons for the higher prevalence of CAD among Indians were often linked to risk factors like hypertension, dyslipidemia, inherent insulin resistance, smoking, etc. These risk factors, coupled along with varying lifestyles and economic burdens, could lead to the development of CAD at a relatively young age. The clinical presentation of CAD among young Indians may often vary from a multi-vessel disease without any clues from risk factors to extensive ischemia in an asymptomatic individual. The less common risk factors for CAD among young adults are coronary vasospasm, medium vessel vasculitis, hypercoagulable states, substance abuse, and embolism. There may be a constant dilemma among clinicians about what specific management strategies are to be adopted in young Indian patients with CAD.

Objectives

To study the clinical profile, angiographic patterns, management, and outcomes of ACS in Young patients presenting to a tertiary health care facility

Materials and Methods

Study Population

Young patients were defined with the age cut off of 40 years. Data from consecutive patients from the tertiary care hospital undergoing intervention shall be retrospectively collected. Based on contemporary practice guidelines, revascularization strategies shall be determined by the Heart Team. The Heart Team comprises Interventional Cardiologists, Cardiac Surgeons, and Physicians. On admission, the Thrombolysis in Myocardial Infarction (TIMI) score shall be assessed to determine the likelihood of ischemic events or mortality in patients with unstable angina or NSTEMI

Type of Study

Prospective EMR based Observational Study

Inclusion Criteria

Age < 40 years
All patients presenting with ACS
Patients undergoing Elective/Rescue PCI

Exclusion Criteria

Age > 40 Years
Patients requiring CABG

Procedure and medication

The PCI strategy and the stent type shall be left to the treating physician’s discretion. ACS patients scheduled for PCI received the same dose of aspirin and ticagrelor or clopidogrel on a diagnosis of ACS. During the procedure, unfractionated heparin (100 U/kg) will be administered to all patients. The use of glycoprotein IIb/IIIa inhibitors will be left to the treating consultant. Post-procedure the patient will be on dual antiplatelet therapy as per the ESC 2021 guidelines.

Patient follow up

All patients shall be followed up by clinical visit or by phone at 1, 6 and 12 months. Thereafter the patients shall be followed up annually. Patients shall be advised to return for complete evaluation if clinically indicated by symptoms or documentation of myocardial infarction.

Definitions used in the Study

Smoking was defined as the inhalation of any form of tobacco at present or in the last year

Hypertension was defined based on the AHA/ACC guidelines for Hypertension.

Diabetes was described as a fasting blood glucose level of > 126 mg/dl or HbA1C of ≥ 6.5 or a patient already diagnosed and on treatment.

A family history of Premature CAD was defined as documented CAD in a first-degree relative (male < 55years, female < 65 years)

Dyslipidemia was defined by the presence of any one of the following: LDL > 130 mg/dl, Total cholesterol >200 mg/dl and HDL < 40 mg/d in men and < 50 mg/dl in women.

Cardiogenic shock was defined as systolic blood pressure (SPB) of < 90 mm Hg for ≥ 30 min or the need to use mechanical support to maintain the SPB ≥ 90 mm Hg

Echocardiography

Two-dimensional (2D) echocardiography was done to assess the left ventricular ejection fraction (LVEF). The ejection fraction (EF) shall be measured using the modified Simpson method.

Normal LVEF was defined as 50-70%
Mild LV Dysfunction was defined as EF 40-49%
Moderate LV Dysfunction was defined as EF 30-39%
Severe LV Dysfunction was defined as EF < 30%

Coronary Angiogram

The angiographic profiles were finalized before starting the Study. The following lesions were considered obstructive

70 % stenosis of the left anterior descending artery (LAD)
70 % stenosis of the right coronary artery (RCA)
70 % stenosis of the left circumflex artery (LCX)
50 % of the Left main coronary artery (LMCA)

Variables proposed to Study

Demographic details

Risk factors

Smoker
Diabetes
Hypertension
Dyslipidemia
Prior MI
Prior Stroke
Insomnia
Family History of Premature CAD

Vitals on Admission

Heart Rate/ Blood Pressure/SpO₂

Laboratory Parameters

CBC/Hb/Urea/Creatinine/Sodium/Potassium/RBS (On admission)/Lipid Profile
ECG Findings
ECHO parameters

Clinical Presentation

STEMI
STEMI
- Unstable angina
TIMI Score
CAG Findings
- LMCA
- LAD
- LCX
- RCA

SYNTAX score

Before Procedure
After Procedure
Unprotected LMCA
Triple vessel Disease
Total Occlusion

Puncture Site

IVUS/ OCT usage
IABP usage

Procedure

Single Stent strategy
Double Stent Strategy
Provisional stenting

Stent Type

Medication at discharge

Death

Ethical Consideration

Consent will be obtained from either the patient or a close family member of the patient before the procedure. The consent will have all the details regarding the option of the treatment as well as the outcomes of the procedure in the local language.

Results

The results of the study shall be analysed and published periodically

Dr. S. Aravindakumar

Chief Consultant Interventional Cardiologist

Dr. Annup Balan B

Associate Consultant, HIC & Microbiology

Dr. Venkita. S. Suresh,

Group Medical Director

Research Protocol