Pro-calcitonin Marker as Indicator of Ischemia in Patients With Complicated Coronary Intervention.
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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. |
- 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 |
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)
Contacts and Locations| United States, New Jersey | |
| Saint Michael's Medical Center | |
| Newark, New Jersey, United States, 07102 | |
| 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 Ischemia Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
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 May 16, 2013