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

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ClinicalTrials.gov Identifier: NCT01609569
Recruitment Status : Unknown
Verified February 2013 by Habib Habib, MD, Saint Michael's Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : June 1, 2012
Last Update Posted : February 22, 2013
Information provided by (Responsible Party):
Habib Habib, MD, Saint Michael's Medical Center

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).

Condition or disease
Coronary Disease

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
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Utility of Pro-calcitonin as an Indicator of Ischemia in Patients Undergoing Percutaneous Coronary Intervention With Subsequent Coronary Complications.
Study Start Date : May 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

coronary complication

patients with coronary complication and patients without coronary complications.

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

Primary Outcome Measures :
  1. Pro-calcitonin blood level [ Time Frame: "0,24 hours post cardiac intervention" ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community sample

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609569

United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
Sponsors and Collaborators
Saint Michael's Medical Center
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

Responsible Party: Habib Habib, MD, Principal Investigator, Saint Michael's Medical Center
ClinicalTrials.gov Identifier: NCT01609569     History of Changes
Other Study ID Numbers: #09/12
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Salmon calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasodilator Agents