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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Habib Habib, MD, Saint Michael's Medical Center
ClinicalTrials.gov Identifier:
NCT01609569
First received: May 29, 2012
Last updated: February 20, 2013
Last verified: February 2013
  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 Saint Michael's Medical Center:

Primary Outcome Measures:
  • Pro-calcitonin blood level [ Time Frame: "0,24 hours post cardiac intervention" ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 29, 2012
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
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
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014