NCT02807714

Brief Summary

The purpose of this study is to find an association between a protein named Podocan and WNT pathway regulatory molecules in patients with different forms of Coronary Artery Disease (Acute Coronary syndrome, Stable Angina and Coronary Artery Restenosis). It has been found in experimental studies that this protein is regulating smooth muscle cell function and hence may be influencing the progression of Coronary Artery Disease (CAD). We are testing to see if the same regulatory function exists in human subjects. Studying patient's blood will possibly enable to identify an association between Podocan and CAD. This may help to better prevent and treat CAD with improved understanding of the mechanism of the disease. No drugs or other therapeutic interventions will be used for the purpose of the research study. Only blood samples will be collected in the cardiac catheterization lab. As a part of this study participants will be followed for repeat events or repeat cardiac catheterization over a period of 24 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
571

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4.5 years

First QC Date

June 17, 2016

Last Update Submit

February 8, 2021

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Podocan levels

    Prior to catheterization, a peripheral blood sample will be obtained via an IV access line previously placed for the catheterization procedure. Blood samples will be frozen and stored in a -80°C freezer in the Research Institute.

    Day 1

  • WNT regulatory molecules

    Prior to catheterization, a peripheral blood sample will be obtained via an IV access line previously placed for the catheterization procedure. Blood samples will be frozen and stored in a -80°C freezer in the Research Institute.

    Day1

Secondary Outcomes (5)

  • Restenosis

    24 months

  • Onset of new lesions

    24 months

  • progression of existing lesions

    24 months

  • New onset MI/ACS

    24 months

  • Death due to known cardiovascular causation

    24 months

Study Arms (4)

No CAD

Patients scheduled for elective cardiac catheterization for evaluation of suspected CAD that are found to not have CAD

Obstructive CAD (non-ACS) Group

Patients scheduled for elective cardiac catheterization for evaluation of known or suspected CAD that are found to have obstructive CAD requiring intervention.

Stable CAD, no intervention required

Patients scheduled for elective cardiac catheterization for evaluation of known or suspected CAD that are found to have non-obstructive CAD not requiring intervention.

Acute Coronary Syndrome (ACS)

Patients who undergo an emergent cardiac catheterization for evaluation of known or suspected STEMI, NSTEMI, Unstable Angina (UA).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for elective cardiac catheterization for known or suspected CAD.

You may qualify if:

  • Age 18 or older
  • Scheduled for coronary angiography in the cardiac catheterization lab
  • Able to provide informed consent

You may not qualify if:

  • Previously enrolled \& sampled in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Randolph Hutter, MD

    Bassett Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Nurse Supervisor

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

US(1)