Coronary DiseaseNCT01609569
Pro-calcitonin Marker as Indicator of Ischemia in Patients With Complicated Coronary Intervention.
An observational study of Coronary Disease, run by Saint Michael's Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- patients older than 18 years old.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Michael's Medical Center
Newark, New Jersey, 07102
About this study
Official title: Utility of Pro-calcitonin as an Indicator of Ischemia in Patients Undergoing Percutaneous Coronary Intervention With Subsequent Coronary Complications.
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).
Read the 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.
- Conditions
- Coronary Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| coronary complication | patients with coronary complication and patients without coronary complications. pro-calcitonin will be measured in both groups to see if any correlation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro-calcitonin blood level
Measured: "0,24 hours post cardiac intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Michael's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habib Habib, MD, Saint Michael's Medical Center
- Investigators
- Habib Habib, MD, Principal investigator, Saint Michael's Medical CenterFayez Shamoon, MD,FACC, Study director, Saint Michael's Medical Centeryaser elnhar, MD, Study chair, Saint Michael's Medical CenterVincent Debari, PhD, Study chair, Saint Michael's Medical CenterAshraf Jmeian, MD, Study chair, Saint Michael's Medical CenterAhmad Isbitan, MD, Study chair, Saint Michael's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609569
- Sponsor's protocol ID
- #09/12
- Status last verified
- Feb 2013
- First submitted
- 29 May 2012
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1253/circj.cj-10-0638. Epub 2011 Mar 3.
PubMed 21378450
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Pro-calcitonin as an Indicator of Ischemia in Patients Undergoing Percutaneous Coronary Intervention With Subsequent Coronary Complications.
- ClinicalTrials.gov ID
- NCT01609569
- Acronym / sponsor ID
- #09/12
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saint Michael's Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary complication | – | –patients with coronary complication and patients without coronary complications. pro-calcitonin will be measured in both groups to see if any correlation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- patients older than 18 years old.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pro-calcitonin blood level
Time frame: "0,24 hours post cardiac intervention"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- Background: PubMed 21378450Sinning 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. doi: 10.1253/circj.cj-10-0638. Epub 2011 Mar 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Habib Habib, MD principal investigator
Saint Michael's Medical Center
Fayez Shamoon, MD,FACC study director
Saint Michael's Medical Center
yaser elnhar, MD study chair
Saint Michael's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Saint Michael's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pro-calcitonin blood level (time frame: "0,24 hours post cardiac intervention"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.