Acute Coronary SyndromeNCT01636427
STEMI Versus NSTEMI: Clinical and Angiographic Differences
An observational study of Acute Coronary Syndrome, run by Federico II University at 1 site in Italy.
Trial summary
The purpose of this study is to assess differences in the risk profile and in the coronary angiographic presentation between STEMI and NSTEMI. Moreover possible relationship between myocardial infarction presentation and renal function will be investigated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to May 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute myocardial infarction with or without ST segment elevation.
Who may be able to join
- Patients admitted in the coronary care unit (CCU) of the Department of Clinical and Experimental Medicine at the Federico 2nd University Hospital;
- Patient with indication to angiographic study even if not immediately;
- Patients referred to CCU with the diagnosis of acute myocardial infraction (AMI), type STEMI, or NSTEMI, based on pre-admission assessment of troponin I (TpI) and myocardial band creatin kinase (CK-MB;
- Diagnosis of NSTEMI/STEMI performed according to standard criteria
Who cannot join
- Patients who could not undergo angiographic study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STEMI Versus NSTEMI: a Mono Versus a Multivessel Disease?
The purpose of this study is to assess differences in the risk profile and in the coronary angiographic presentation between STEMI and NSTEMI. Moreover possible relationship between myocardial infarction presentation and renal function will be investigated.
Read the detailed description
Assessment of risk profile. Diabetes mellitus diagnosed when fasting blood glucose (FBG) was >= 126mg/dL or if patients were taking oral hypoglycaemic drugs or were on insulin treatment. Hypertension defined as blood pressure >= 140/90 mmHg or history of antihypertensive treatment. Hypercholesterolemia,adjudicated when cholesterol levels were >= 200 mg/dL or with patients on lipid lowering treatment. Hypertriglyceridemia adjudicated on fasting triglyceride levels>= 200 mg/dL or triglyceride-lowering therapy . Obesity, defined as BMI >= 30 kg/m2.
Patients with STEMI, who had not been previously treated with thrombolysis, and those who had been undergone to an unsuccessful thrombolysis, as well as patients with NSTEMI with a TIMI score> 3 who were immediately referred to the Cat Lab and whenever possible treated with PTCA and stenting of the culprit lesion. The other patients who were referred to Cat Lab within 48 hours from the beginning of chest pain, unless their general conditions did not strongly suggest to delay the procedure after 2 more days.
- Conditions
- Acute Coronary Syndrome
- Keywords
- myocardial infarction, coronary angiography, STEMI, NSTEMI
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJan 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferrara Liberato Aldo, Federico II University
- Investigators
- Giovanni de Simone, MD, Study director, Federico 2nd University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636427
- Sponsor's protocol ID
- 001
- Status last verified
- Jul 2012
- First submitted
- 6 Jul 2012
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferrara LA, Staiano L, Di Fronzo V, Ferrara F, Sforza A, Mancusi C, de Simone G. Type of myocardial infarction presentation in patients with chronic kidney disease. Nutr Metab Cardiovasc Dis. 2015 Feb;25(2):148-52. doi: 10.1016/j.numecd.2014.11.002. Epub 2014 Nov 11.
PubMed 25511783Ferrara LA, Russo BF, Gente R, Esposito G, Rapacciuolo A, de Simone G. STEMI and NSTEMI: a mono versus a multivessel disease? Int J Cardiol. 2013 Oct 3;168(3):2905-6. doi: 10.1016/j.ijcard.2013.03.154. Epub 2013 May 3. No abstract available.
PubMed 23643429
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEMI Versus NSTEMI: a Mono Versus a Multivessel Disease?
- ClinicalTrials.gov ID
- NCT01636427
- Acronym / sponsor ID
- 001
- Conditions
- Acute Coronary Syndrome
- Keywords
- myocardial infarction, coronary angiography, STEMI, NSTEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Jul 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 purpose of this study is to assess differences in the risk profile and in the coronary angiographic presentation between STEMI and NSTEMI. Moreover possible relationship between myocardial infarction presentation and renal function will be investigated.
Detailed description
Assessment of risk profile. Diabetes mellitus diagnosed when fasting blood glucose (FBG) was >= 126mg/dL or if patients were taking oral hypoglycaemic drugs or were on insulin treatment. Hypertension defined as blood pressure >= 140/90 mmHg or history of antihypertensive treatment. Hypercholesterolemia,adjudicated when cholesterol levels were >= 200 mg/dL or with patients on lipid lowering treatment. Hypertriglyceridemia adjudicated on fasting triglyceride levels>= 200 mg/dL or triglyceride-lowering therapy . Obesity, defined as BMI >= 30 kg/m2.
Patients with STEMI, who had not been previously treated with thrombolysis, and those who had been undergone to an unsuccessful thrombolysis, as well as patients with NSTEMI with a TIMI score> 3 who were immediately referred to the Cat Lab and whenever possible treated with PTCA and stenting of the culprit lesion. The other patients who were referred to Cat Lab within 48 hours from the beginning of chest pain, unless their general conditions did not strongly suggest to delay the procedure after 2 more days.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute myocardial infarction with or without ST segment elevation.
Key inclusion criteria (4 listed)
- Patients admitted in the coronary care unit (CCU) of the Department of Clinical and Experimental Medicine at the Federico 2nd University Hospital;
- Patient with indication to angiographic study even if not immediately;
- Patients referred to CCU with the diagnosis of acute myocardial infraction (AMI), type STEMI, or NSTEMI, based on pre-admission assessment of troponin I (TpI) and myocardial band creatin kinase (CK-MB;
- Diagnosis of NSTEMI/STEMI performed according to standard criteria
Key exclusion criteria (1 listed)
- Patients who could not undergo angiographic study
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Derived from this study: PubMed 25511783Ferrara LA, Staiano L, Di Fronzo V, Ferrara F, Sforza A, Mancusi C, de Simone G. Type of myocardial infarction presentation in patients with chronic kidney disease. Nutr Metab Cardiovasc Dis. 2015 Feb;25(2):148-52. doi: 10.1016/j.numecd.2014.11.002. Epub 2014 Nov 11.
- Derived from this study: PubMed 23643429Ferrara LA, Russo BF, Gente R, Esposito G, Rapacciuolo A, de Simone G. STEMI and NSTEMI: a mono versus a multivessel disease? Int J Cardiol. 2013 Oct 3;168(3):2905-6. doi: 10.1016/j.ijcard.2013.03.154. Epub 2013 May 3. No abstract available.
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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.
Giovanni de Simone, MD study director
Federico 2nd University of Naples
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 Acute Coronary Syndrome, run by Federico II University at 1 site in Italy.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jul 2012. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01636427, which also lists 2 linked publications.
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 18 Jul 2012.