跳至主要内容
临床试验/CTRI/2013/09/003965
CTRI/2013/09/003965招募中不适用

Role of Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome.

FATHER MULLER MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年2月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
EXPECTED CHANGES IN SERUM PARAMETERS.

研究概览

简要总结

Brief resume of the work

6.1 Need for the study

Cardiovasculardisease is responsible for 30% of all deaths in theworld.About 80% of the global burden of CVD  deaths occur in low and middle income countries. India carries a significant portion of this CVD burden .India suffers one of the highest CVD case fatality rates in the world according to an international registry (OASIS) comparing the outcome among patients of Acute Coronary Syndrome.(1)

Until now various bio-markers have been studied in patients of Acute coronary syndrome. However, no single marker gives definite prognostic information during the course of the disease. Little information is available about the role of different individual bio markers .Hence a comparative study is attempted using 3 easily measured ,broadly available bio-markers namely serum Uric Acid, troponin-T and C reactive protein targeting different risk indicators like purine metabolism, cardiac myocyte injury and inflammation.

Acute coronary Syndrome encompasses MI(STEMI and NSTEMI) and Unstable Angina .

Diagnostic criteria (2) (3)

1.      Chest discomfort (with or without radiation to the arms, back , neck jaw or epigastrium) or anginal equivalents such as shortness of breath, diaphoresis or extreme fatigue.

  1. 12 lead ECG with ST segment elevation in STEMI and ST   segment  depression or prominent T wave inversion or absence of ST segment Elevation with positive biomarkers of necrosis(troponin T) for NSTEMI

  2. Elevated cardiac bio markers like troponin-T.

 6.2 Review of Literature

1.Peter A. Kasak and group measured CRP in 446 emergency department patients with acute coronary syndromes. All-cause mortality and hospital discharges for acute myocardial infarction and congestive heart failure were obtained for period of eight years following the event. Kaplan-Meier analyses indicated that the patients with CRP concentrations above the American Heart Association scientific statement cut off 10 mg/ml had a higher rate of death and CHF admissions .Study concluded that patients presenting early with chest pain with elevated CRP concentrations have a greater long term risk for death and heart failure.(4)

  1. MY Nadkar and V I Jain studied 100 patients with acute myocardial infarction and 50 controls. Serum uric acid level was measured on day 0,3 and 7 of MI. On all the days serum uric acid levels were higher in patients who were in higher Killip class. Study concluded that serum uric acid levels are higher in patients of acute myocardial infarction correlated with Killip classification.(5)

  2. S.M.N.A Nadeem K and group studied 255 consecutive patients admitted with diagnosis of unstable angina and non STEMI . All patients had a baseline troponin T estimation done and repeated twelve hours later in case of an initial negative result. . Study concluded that positive troponin T in patients with UA/NSTEMI is a strong , independent risk predictor of future death and MI.(6)

6.3 Objective of the study:

To assess the role of Serum uric acid , C-reactive protein and troponin T as best prognostic indicator in patients of Acute Coronary syndrome  admitted in Father Muller Medical College Hospital.

  |Materials and Methods

7.1 Source of data:

The data will be collected from patients admitted in Father Muller’s Medical College Hospital with acute coronary syndrome  from 1st August 2011 to 1st August 2012.

7.2. Method of collection of data:

STUDY DESIGN

The study will be a descriptive prospective study of the patients admitted in Father Muller’s Medical College with Acute coronary syndrome

The study will include a minimum of 40 patients diagnosed with acute coronary syndrome .Three bio markers namely troponin-T, serum Uric acid and CRP will be measured on day 0 .Troponin t will be measured by Dry Chemistry (turbidimetric method) and will be repeated after twelve hours if initially found negative, Uric acid by Uricase method and CRP by turbidimetric method. Patients will be followed up over a period of seven days. Death ,Heart failure(Killip class I to IV), recurrent ACS and LV ejection fraction will be taken as end points of the study . All the values will be statistically compared to determine a single bio marker predicting the prognosis.

Inclusion Criteria

(1)Age greater than or equal to 18 years.

(2)Patients with first episode of Acute Coronary Syndrome.

Exclusion Criteria

(1*)*Patients with chronic kidney disease.

(2) Gout, haematological malignancy ,hypothyroidism, patients on drugs raising uric acid level.

(3*)*Patients in sepsis.

(4) Patients suffering from connective tissue disorders.

Data Analysis: Data will be analyzed by frequency , percentage , mean, standard deviation, ANOVA and Chi-Square.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals?

YES

The following investigations will be done

Routine blood investigations- Haemoglobin, total cell count and differential count.

Urine  microscopy, serum creatinine.

ECG , 2 D ECHO , troponin -T, Serum Uric acid and CRP.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age greater than or equal to 18 years.
  • (2)Patients with first episode of Acute Coronary Syndrome.

排除标准

  • Patients with chronic kidney disease.
  • (2) Gout, haematological malignancy ,hypothyroidism, patients on drugs raising uric acid level.
  • (3)Patients in sepsis.
  • (4) Patients suffering from connective tissue disorders.

结局指标

主要结局

EXPECTED CHANGES IN SERUM PARAMETERS.

时间窗: EXPECTED CHANGES IN SERUM PARAMETERS.

次要结局

  • Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome.(Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome.)

研究者

发起方
FATHER MULLER MEDICAL COLLEGE
申办方类型
Private medical college

研究点 (1)

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