Dynamic Changes in Stromal Cell-derived Factor-1α Levels in Acute and Stabilized Heart Disease - ACUTE MYOCARDIAL INFARCTION, ATRIAL FIBRILLATION, AND HEART FAILURE (THE DYNASDY STUDY)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Dynamic changes in SDF-1α levels for use as a prognostic factor during and after treatment of Acute Myocardial Infarction, Atrial Fibrillation and Heart Failure.
Study Overview
Brief Summary
The aims of the present study are to measure dynamic changes over time in the plasma level of SDF-1α in patients with confirmed diagnoses of AMI, AF and CHF and in so doing:
- Monitor the plasma level of SDF-1α at the diagnosis, during and after the long term treatment of AMI, AF and CHF. The SDF-1α level of patients is expected to decrease during treatment of the aforementioned conditions.
- Correlate the plasma level of SDF-1α in relation to clinical, biochemical characteristics of Acute Myocardial Infarction(AMI), Atrial Fibrillation(AF) and Congestive Heart Failure (CHF). In so doing, the investigators expect that SDF-1α will correlate with the severity of heart disease.
- Study the dynamic of SDF-1α pertaining to its property as prognostic indicator for the long term follow up risk of readmission and mortality of patients diagnosed with AMI, AF or CHF.
Detailed Description
The study considers changes in SDF-1α levels in response to treatment of cardiac disease (myocardial infarction, heart failure or atrial fibrillation). SDF-1α levels will be measured at the acute stages of the disease, after stabilization and at longer term as detailed below. Levels of SDF-1α will be correlated to the outcome of disease.
BLOOD SAMPLING AND MEASUREMENT OF SDF-1Α A blood sample of about 5 ml will be sampled by peripheral venepuncture and anticoagulated with heparin. Blood samples will be spun for 15 minutes at 1000g within 30 minutes of collection. The resulting plasma will be stored at -80°C until analysis. Levels of SDF-1α in the plasma will be determined using a commercially available ELISA kit according to the manufacturer's instructions.
Analyses will be performed at the Clinical Research Centre, Copenhagen University Hospital Hvidovre.
PATIENTS Patients are included from the in-patient department of the Department of Cardiology, Hvidovre University Hospital. Patients are eligible for inclusion if diagnosed with myocardial infarction, atrial fibrillation or heart failure, provided they do not suffer from malignant disease, diabetes mellitus types I or II and have a life expectancy of at least one year.
Exclusion criteria are based upon the fact that serum SDF-1α levels are elevated in malignant diseases as SDF-1α contributes to neoangiogenesis of the tumour mass, and SDF-1α levels have recently been demonstrated to be elevated in diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients are included from the in-patient department of the Department of Cardiology, Hvidovre University Hospital. Patients are eligible for inclusion if diagnosed with one of the following diseases:
- •myocardial infarction
- •atrial fibrillation
- •heart failure
Exclusion Criteria
- •Patients must not suffer from one of the follwing conditions:
- •malignant disease
- •diabetes mellitus types I or II
- •have a life expectancy of at least one year.
Outcomes
Primary Outcomes
Dynamic changes in SDF-1α levels for use as a prognostic factor during and after treatment of Acute Myocardial Infarction, Atrial Fibrillation and Heart Failure.
Time Frame: 6 months
This study aims to evaluate the dynamic changes in SDF-1α levels during and after treatment of three major heart diseases. Results will aid in the understanding of the role of SDF-1α in cardiac disease. If disease progression and treatment effect is reflected in the levels of SDF-1α, measurement of this biomarker will be a valuable tool for monitoring disease course and treatment effect and, in so doing, help in risk evaluation and individualized treatment of patients suffering from cardiac disease.
Secondary Outcomes
No secondary outcomes reported
Investigators
Lawkesh Vimal Hurry
M.D.
Copenhagen University Hospital, Hvidovre