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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Habib Habib, MD, Saint Michael's Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609569
First Posted: June 1, 2012
Last Update Posted: February 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Habib Habib, MD, Saint Michael's Medical Center
  Purpose
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
Coronary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Utility of Pro-calcitonin as an Indicator of Ischemia in Patients Undergoing Percutaneous Coronary Intervention With Subsequent Coronary Complications.

Resource links provided by NLM:


Further study details as provided by Habib Habib, MD, Saint Michael's Medical Center:

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

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
coronary complication

patients with coronary complication and patients without coronary complications.

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


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.

  Eligibility

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
Criteria

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)
  Contacts and Locations
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


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

Publications:
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 Submitted: May 29, 2012
First Posted: June 1, 2012
Last Update Posted: February 22, 2013
Last Verified: February 2013

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