Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03727542
Other study ID # IU-1140
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date November 15, 2018

Study information

Verified date December 2018
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As potential biomarkers of pressure-related aortic damage, matrix metalloproteinases (MMP) have been implicated in the pathogenesis of aortic aneurysm because of the important role they play in connective tissue homeostasis. In particular, a significant reduction in initially elevated serum MMP - 9 concentrations, compared with healthy controls, demonstrated after the aortic repair in patients with abdominal aortic aneurysm implies MMPs pivotal role in aortic aneurysms. Besides, due to an active degradation and repair processes taking place in the vascular wall governed by the balance between MMP enzymes and their inhibitors, MMP - 9, expression of which is predominantly associated with disruption of aortic elastic fibers, can also be detected in the serum of healthy subjects. Indeed, mechanical stress-induced upregulation of genes and their products stimulate MMP expression in the vascular wall, which is responsible for extracellular matrix degradation. Herein, it was hypothesized that reducing the acceleration rate of aortic pressure (aortic peak dP/dt) may decrease the mechanical stretch on the aortic wall which, may in turn, reduce the expression and serum levels of MMP-9.


Description:

The maximum value of acceleration rate of aortic pressure rise can be named as aortic peak dP/dt. It, likewise, corresponds to the maximum value of first derivative of aortic pressure curve with respect to time.Notably, aortic peak dP/dt would be one of the principal determinants of mechanical stress applied to the aortic wall. Hence, interventions aiming to reduce aortic peak dP/dt levels may open a new therapeutic avenue in the management of pressure-related vascular damages such as aortic aneurisms.

Since it is the principle determining factor of aortic peak dP/dt, changing LV contractility, thereby LV peak dP/dt, may be expected to lead to change aortic peak dP/dt values in the same direction. Therefore, reduction of LV dP/dt can lead to a reduction in aortic dP/dt. Previous finding strongly suggest that widening of the QRS complex could decrease LV contractility and correspondingly LV peak dP/dt value which may eventually lead to a reduction in aortic peak dP/dt.

From biomechanical point of view, as potential biomarkers of pressure-related aortic damage, matrix metalloproteinases (MMP) have been implicated in the pathogenesis of aortic aneurysm because of the important role they play in connective tissue homeostasis. In particular, a significant reduction in initially elevated serum MMP - 9 concentrations, compared with healthy controls, demonstrated after the aortic repair in patients with abdominal aortic aneurysm implies MMPs pivotal role in aortic aneurysms. Besides, due to an active degradation and repair processes taking place in the vascular wall governed by the balance between MMP enzymes and their inhibitors, MMP - 9, expression of which is predominantly associated with disruption of aortic elastic fibers, can also be detected in the serum of healthy subjects. Indeed, mechanical stress-induced upregulation of genes and their products stimulate MMP expression in the vascular wall, which is responsible for extracellular matrix degradation. Herein, we hypothesized that reducing the acceleration rate of aortic pressure (aortic peak dP/dt) may decrease the mechanical stretch on the aortic wall which, may in turn, reduce the expression and serum levels of MMP-9.

To this end, in the current trial, effect of the prolongation of QRS duration over a certain period of time by short AVD permanent pacing on the circulating levels of a vascular extracellular matrix degradation marker, MMP-9, was examined.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 15, 2018
Est. primary completion date November 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Normal LV systolic function (EF>50%),

- Healthy conduction systems

- Noncritical coronary stenoses or normal coronary arteries

- Ventricular pacing rate <10% in the last 6 months detected at the interrogation of the pacemakers

Exclusion Criteria:

- Intra-ventricular conduction abnormalities (baseline QRS >100 msec.),

- Mild to moderate aortic or mitral valve disease

- Presence of atrial fibrillation

- LV systolic dysfunction

Study Design


Related Conditions & MeSH terms


Intervention

Device:
adjustment of atrioventricular delay in DDD packers
Atrioventricular delays are going to be adjusted as 60 milisecond shorter than the patients' native PR intervals in patients with already implanted permanent pacemakers.

Locations

Country Name City State
Turkey Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in MMP - 9 serum concentration from baseline to at the end of 3 weeks follow-up MMP-9 serum concentration will be measured before and after short AV delay (wide QRS) pacing. Change in MMP-9 levels will be measured. 3 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Enrolling by invitation NCT04035356 - HAART Annuloplasty Device Valve Repair Registry
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Completed NCT02283307 - Dual Energy CT Urography With Reduced Iodinated Contrast N/A
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Terminated NCT01055275 - Cook Iliac Branch Graft Post-market Registry N/A
Completed NCT00615888 - Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair N/A
Completed NCT03510793 - Microcirculation and Anesthesia in Vascular Surgery
Completed NCT03207568 - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Not yet recruiting NCT01918982 - Circulating Endothelial Progenitor Cells and Aortic Aneurysm N/A
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Not yet recruiting NCT01918969 - Reference Values of Circulating Endothelial Progenitor Cells N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Recruiting NCT00661518 - PET/CT Imaging of Aneurysm Wall Inflammation N/A
Completed NCT00094575 - Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) Phase 4
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Recruiting NCT05603520 - Phenotyping Heterogeneity and Regionality of the Aorta
Not yet recruiting NCT05531084 - Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms N/A