Association Between Inflammatory Biomarkers and LV Function in Patients With CVD

• Sponsor: Damanhour University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05911724
• Collaborator: Tanta University (Other)
• Enrollment: 180
• Location: 1
• Anticipated Duration (Months): 3.7
• Patients Per Site Per Month: 48.5

Study Details

Study Description

Brief Summary

The association of novel inflammatory biomarkers with cardiovascular diseases is still obscure. The present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission. Methods: We enrolled a total of 120 patients with HF, asymptomatic CAD and 60 healthy controls (HC) without cardiovascular diseases.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina; Heart Failure	Other: Group I; Other: Group II; Other: Group III

Detailed Description

• The present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission.

• We enrolled a total of 60 patients with HF, 60 asymptomatic CAD patients and 60 healthy controls (HC) without cardiovascular diseases.

Group I: 60 Healthy Subjects. Group II: 60 Patients with Stable Angina (asymptomatic CAD). Group III: 60 Patients with Heart Failure.

• Clinical parameters, glycemic and lipid profile, vaspin, visfatin, high-sensitivity C-reactive protein, sortilin, homocysteine, troponin I, fetuin A and lipoprotein A levels were assayed.

• Patients will be followed up to assess all-cause 30- and -90 day of hospital readmission.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 180 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Prognostic Significance of Inflammatory Biomarkers and LV Functionin Patients With Coronary Heart Disease and Heart Failure.
• Actual Study Start Date: Apr 10, 2023
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group I 60 Healthy Subjects.	Other: Group I; Healthy Subjects
Group II 60 Patients with Stable Angina.	Other: Group II; Stable Angina Patients
Group III 60 Patients with Heart Failure.	Other: Group III; Heart Failure Patients

Outcome Measures

Primary Outcome Measures

1. All Cause 30 day hosptial admission [1 month]

   Number of patients admited to hospital during 1 month.

2. All Cause 90 day hosptial admission [3 months]

   Number of patients admited to hospital during 3 month.

3. vaspin (ng/ml) [1 month]

   vaspin blood concentration

4. visfatin (ng/ml) [1 month]

   visfatin blood concentration

5. Sortillin (pg/ml) [1 month]

   Sortillin blood concentration

6. Homocystien(umol/L) [1 Month]

   Homocystien blood concentration

7. Troponin.I (ng/ml) [1 Month]

   Troponin.I blood concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Either sex, aged 18 years or older.

• new-onset AHF or acute decompensation of chronic HF,

• CAD (including previous myocardial infarction, previous percutaneous or surgical coronary revascularization, or angiographic evidence that one or more major coronary arteries had narrowed by 50% or more).

Exclusion Criteria:

• severe liver/

• kidney dysfunction;

• severe systemic disease (such as the diseases of respiratory system/ digestive system/ nervous system etc.);

• malignant tumor;

• acute/ chronic infectious diseases;

• autoimmune disease or connective tissue disease;

• major trauma or surgical operation over the past three months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospital	Tanta	El-Gharbia	Egypt	31527

Sponsors and Collaborators

• Damanhour University
• Tanta University

Investigators

• Study Director: Ibtsam Khairat, Ass. Prof., Tanta University
• Principal Investigator: Ahmed A. El-Sherbeni, Lecturer, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Eisen A, Benderly M, Behar S, Goldbourt U, Haim M. Inflammation and future risk of symptomatic heart failure in patients with stable coronary artery disease. Am Heart J. 2014 May;167(5):707-14. doi: 10.1016/j.ahj.2014.01.008. Epub 2014 Feb 22.
• Held C, White HD, Stewart RAH, Budaj A, Cannon CP, Hochman JS, Koenig W, Siegbahn A, Steg PG, Soffer J, Weaver WD, Ostlund O, Wallentin L; STABILITY Investigators. Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10):e005077. doi: 10.1161/JAHA.116.005077.
• Konig P, Mayer O, Bruthans J, Seidlerova J, Materankova M, Gelzinsky J, Rychecka M, Karnosova P, Wohlfahrt P, Cifkova R, Filipovsky J. The prognostic importance of subclinical heart failure in stable coronary heart disease patients. Acta Cardiol. 2020 Aug;75(4):329-336. doi: 10.1080/00015385.2019.1590958. Epub 2019 Apr 3.
• Papaioannou V, Pneumatikos I, Maglaveras N. Association of heart rate variability and inflammatory response in patients with cardiovascular diseases: current strengths and limitations. Front Physiol. 2013 Jul 10;4:174. doi: 10.3389/fphys.2013.00174. eCollection 2013.
• Williams ES, Shah SJ, Ali S, Na BY, Schiller NB, Whooley MA. C-reactive protein, diastolic dysfunction, and risk of heart failure in patients with coronary disease: Heart and Soul Study. Eur J Heart Fail. 2008 Jan;10(1):63-9. doi: 10.1016/j.ejheart.2007.11.003. Epub 2007 Dec 21.

• Responsible Party: Rehab Werida, Associate Professor, Damanhour University
• ClinicalTrials.gov Identifier: NCT05911724
• Other Study ID Numbers: inflammatory biomarkers in CVD
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rehab Werida, Associate Professor, Damanhour University: vaspin; visfatin; lipoprotein A; high-sensitivity C-reactive protein; sortilin; homocysteine; troponin I; fetuin A
• Additional relevant MeSH terms: Heart Failure; Angina, Stable

Study Results

No Results Posted as of Jun 23, 2023