NCT01609569

Brief Summary

The aim of this study is to determine on preliminary basis weather an elevated pro-calcitonin level can be used to assess ischemia as a result of coronary artery complications during percutaneous coronary intervention (PCI).

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

1.9 years

First QC Date

May 29, 2012

Last Update Submit

February 20, 2013

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

  • Pro-calcitonin blood level

    "0,24 hours post cardiac intervention"

Study Arms (1)

coronary complication

patients with coronary complication and patients without coronary complications. pro-calcitonin will be measured in both groups to see if any correlation.

Eligibility Criteria

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

Community sample

You may qualify if:

  • patients older than 18 years old.

You may not qualify if:

  • no consent.
  • suspicion of sepsis.
  • Patients with elevated troponin or procalcitonin before enrollment.
  • patients who had non-elective angioplasty (e.g. rescue angioplasty, primary angioplasty, salvage angioplasty, or emergency angioplasty)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Related Publications (1)

  • Sinning CR, Sinning JM, Schulz A, Schnabel RB, Lubos E, Wild PS, Papassotiriou J, Bergmann A, Blankenberg S, Munzel T, Bickel C; AtheroGene Study Investigators. Association of serum procalcitonin with cardiovascular prognosis in coronary artery disease. Circ J. 2011;75(5):1184-91. doi: 10.1253/circj.cj-10-0638. Epub 2011 Mar 3.

    PMID: 21378450BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Habib Habib, MD

    Saint Michael's Medical Center

    PRINCIPAL INVESTIGATOR

  • Fayez Shamoon, MD,FACC

    Saint Michael's Medical Center

    STUDY DIRECTOR

  • yaser elnhar, MD

    Saint Michael's Medical Center

    STUDY CHAIR

  • Vincent Debari, PhD

    Saint Michael's Medical Center

    STUDY CHAIR

  • Ashraf Jmeian, MD

    Saint Michael's Medical Center

    STUDY CHAIR

  • Ahmad Isbitan, MD

    Saint Michael's Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 1, 2012

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

US(1)