Dynamic Changes in SDF-1α Levels in Acute and Stabilized Heart Disease

NCT02702752 | Unknown DMC

• 1 other identifier: H-15007626
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

1. 1.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.
2. 2.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.
3. 3.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.

Conditions

Atrial Fibrillation; Ischemic Heart Disease; Congestive Heart Failure

Keywords

Heart diseases stromal differentiation factor alpha 1

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  6 months

Study Arms (2)

DYNASDY

OTHER

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.

Other: DYNASDY

Control group

ACTIVE COMPARATOR

A control group of 20 subjects without cardiac disease (including hypertension), diabetes, hypercholesterolemia, and malignant disease.

Other: DYNASDY

Interventions

DYNASDY OTHER

Measurement of SDF-1 alpha levels i patients' blood samples.

Control group; DYNASDY

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• myocardial infarction
• atrial fibrillation
• heart failure

You may not qualify if:

• malignant disease
• diabetes mellitus types I or II
• have a life expectancy of at least one year.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, Capital Region of Denmark, 2650, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation; Myocardial Ischemia; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Nadia Landex, Ph.D.

  Department of Cardiology, Roskilde University Hospital

  STUDY CHAIR

• Ema Ema Rastoder, MB

  Department of Cardiology, Copenhagen University Hospital Hvidovre

  STUDY CHAIR

• Maha Maha Alsawaf, MB

  Department of Cardiology, Copenhagen University Hospital Hvidovre

  STUDY CHAIR

• Anne Langkilde, MS, Ph.D.

  Clinical Research Centre, Copenhagen University Hospital Hvidovre

  STUDY DIRECTOR

• Ove Andersen, M.D., Ph.D.

  Clinical Research Centre, Copenhagen University Hospital Hvidovre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: March 9, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 31, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)