NCT02060071

Brief Summary

There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the aortic valve.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

2.6 years

First QC Date

February 3, 2014

Last Update Submit

February 9, 2014

Conditions

Aortic StenosisCardiac Death

Keywords

aortic stenosis

Outcome Measures

Primary Outcomes (1)

  • Cardiac death or need for intervantion in correlation to endothelial progenitor cells

    We will assess wether endothelial progenitor cells can predict outcome

    4 years

Study Arms (2)

Aortic setnsosi

OTHER

blood test

Other: Blood test

controls

OTHER

blood test

Other: Blood test

Interventions

Blood testOTHER

Blood test

Aortic setnsosicontrols

Eligibility Criteria

Age18 Years - 92 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Aortic stenosis
  • Control with aortic stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, 7610001, Israel

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisDeath

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sara Shimoni, MD

    Kaplan Medical

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Shimoni, MD

CONTACT

972-505759131sara_s@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Director of non Invasive Cardiology Unit

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 11, 2014

Study Start

July 1, 2011

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

IL(1)