Pro-calcitonin Marker as Indicator of Ischemia in Patients With Complicated Coronary Intervention.

February 20, 2013 updated by: Habib Habib, MD, Saint Michael's Medical Center

Utility of Pro-calcitonin as an Indicator of Ischemia in Patients Undergoing Percutaneous Coronary Intervention With Subsequent Coronary Complications.

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).

Study Overview

Status

Unknown

Conditions

Detailed Description

Pro-calcitonin is a type of protein found in the blood. This protein has recently be found to be elevated in patients with diseases of the arteries of the heart such as heart attack.

Percutaneous coronary intervention (PCI) is widely used in the treatment of many patients with blockage in the arteries of the heart.

the investigators normally used a marker called troponin after cardiac catheterization. However, this marker may not be specific.

Pro-calcitonin has been found to be a useful marker for the detection of myocardial injury. the value of Pro-calcitonin as a marker for the identification of myocardial damage undergoing PCI has not yet been studied.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

  • patients older than 18 years old.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
coronary complication

patients with coronary complication and patients without coronary complications.

pro-calcitonin will be measured in both groups to see if any correlation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pro-calcitonin blood level
Time Frame: "0,24 hours post cardiac intervention"
"0,24 hours post cardiac intervention"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Michael's Medical Center

Investigators

  • Principal Investigator: Habib Habib, MD, Saint Michael's Medical Center
  • Study Director: Fayez Shamoon, MD,FACC, Saint Michael's Medical Center
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #09/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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