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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01609569
• Other study ID #: #09/12
• Status: Active, not recruiting
• Phase: N/A
• First received: May 29, 2012
• Last updated: February 20, 2013
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: February 2013
• Source: Saint Michael's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
United States	Saint Michael's Medical Center	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Saint Michael's Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sinning CR, Sinning JM, Schulz A, Schnabel RB, Lubos E, Wild PS, Papassotiriou J, Bergmann A, Blankenberg S, Munzel T, Bickel C; AtheroGene Study Investigators. Association of serum procalcitonin with cardiovascular prognosis in coronary artery disease. Circ J. 2011;75(5):1184-91. Epub 2011 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pro-calcitonin blood level		"0,24 hours post cardiac intervention"	No