Health Condition 1: I238- Other current complications following acute myocardial infarction
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Dr Aruna Kale
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants with age group of 18-80 years. 2. Participants with willingness to provide an informed consent. 3. Participants who are on Clopidogrel antiplatelet therapy due to any reason. 4. Participants with documented major or minor ADRs due to Clopidogrel therapy. a. Participants with changes in CAG/ CTA stenosis of artery documented peripheral arterial disease (PAD) and participant who is diagnosed with coronary heart disease. b. Participants with major adverse cardiovascular events (MACEs with STEMI) ST-elevation c. Participants with evidence of myocardial infarction and who are on Clopidogrel antiplatelet therapy. d. Participants who have history of CVD with MI (ST elevation or non-ST elevation MI). e. Participants who are advised or undergone PTCA or CABG or surgical revascularization, minimally invasive heart surgery/ intervention. f. Stroke g. Abnormal (raised) laboratory values e.g PTINR/ BT CT/ TRPOP- I, TROP -T, CPK-MB, Raised lipid profile, LFT, RFT or CBC h. Acute Coronary syndrome i. Atherosclerotic Vascular disease. j. Minor or major risk of bleeding. k. Thrombocytopenia, Purpura, Neutropenia l. headache, dizziness, Nausea, vomiting, stomach pain
Exclusion criteria
Exclusion criteria: Exclusion Criteria The participants with the following factors will not be considered for the study. 1. Pregnant / Lactating women. 2. Patients who have completed participation in any other clinical trial during the past six (6) months. 3. The participants who are not willing to participate give voluntary informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse drug reactions (ADRs) are often under evaluated and misdiagnosed, despite being a significant cause of both morbidity and mortality across the globe. The current study will help to understand various aspects of genetics associated with adverse reactions to drug safety The study will also help to identify different genetic risk factors predominantly for idiosyncratic ADRs which may significantly decline morbidity and mortality and reduce healthcare costs.Timepoint: 6 months: Preliminary planning of study 1.Literature review 2.Preparation of study pro forma and other research material 3.Submission of research protocol for approval from Institutional Ethics Committee. 8 months: Data collection process 1.Selection of study participants 2. Genetic sampling collection. 3.Management/storage and analysis of samples. 5 months: Data management 1.Consolidation of data. 2.Statistical analysis and interpretation. 5 months: Report writing 1.Preparation of preliminary draft. 2.Revising and finalization of draft. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proposed study has the potential to have a direct impact on health services and assist in shaping healthcare practices specifically related to drug management. The emerging results from the study will help to evaluate underlying mechanisms related to pharmacogenomics of ADRs of short-term as well as long-term dose adjustment and subsequently avoidance of drug toxicity.Timepoint: The generated knowledge from this study will help the research and healthcare system to understand the genetic basis of ADR. | — |
Countries
India
Contacts
Public ContactDr Aruna kale
Seth GSMC and KEMH Parel Mumbai Maharashtra 400012
Outcome results
None listed