Metabolic SyndromeNCT02054390
Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction
An observational study of Metabolic Syndrome and Coronary Artery Disease, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the present cohort study is to investigate whether ACEi therapy reduces the rate of periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention (PCI) among patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Syndrome, Coronary Artery Disease
- How many people
- 459 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2014to Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metabolic syndorme (MS) was defined as the presence of 3 or more of these components: 1. high fasting glucose (fasting serum glucose ≥100 mg/dl or drug treatment for elevated blood glucose) 2. abdominal obesity (given as waist circumference >102 cm in men and >88 cm in women) 3. high blood pressure (>130/>85 mmHg or drug treatment for hypertension) 4. hypertriglyceridemia (serum triglycerides ≥150 mg/dl) 5. low high-density lipoprotein (HDL) cholesterol (<40 mg/dl in men and <50 mg/dl in women).
Who may be able to join
- metabolic syndrome
- elective percutaneous coronary intervention with angiographically successful stent implantation
Who cannot join
- acute coronary events
- renal failure
- needed the use of IV glycoprotein IIb/IIIa receptor inhibitors were excluded
- left main coronary artery disease
- chronic total occlusion
- high levels of baseline CKMB or troponin
- any contraindication of aspirin, clopidogrel or ACEi treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School Of Medicine, Department of Cardiology
Ankara, 06230
About this study
Official title: Angiotensin Converting Enzyme Inhibitor Therapy and Periprocedural Myocardial Infarction in Patients With Metabolic Syndrome
Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the present cohort study is to investigate whether ACEi therapy reduces the rate of periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention (PCI) among patients with metabolic syndrome.
- Conditions
- Metabolic Syndrome, Coronary Artery Disease
- Keywords
- Angiotensin converting enzyme inhibitor, inflammation, metabolic syndrome, myonecrosis, percutaneous coronary intervention, periprocedural myocardial injury
- Medical subject headings
- Metabolic Syndrome, Coronary Artery Disease, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprocedural myocardial injury (MI)
Periprocedural MI was defined as cardiac Troponin I release [5 times ULN] 24 hours after percutaneous coronary intervention
Measured: 24 hours after (percutaneous coroary intervention) PCI
Secondary outcomes (1)
Periprocedural myonecrosis
Peri-procedural myonecrosis was defined as troponin I release of >1×ULN 24 hours after the intervention.
Measured: 24 hours after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Ulaş Özcan, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054390
- Sponsor's protocol ID
- ACEmetsend
- Status last verified
- Jun 2014
- First submitted
- 3 Feb 2014
- Last updated
- 20 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin Converting Enzyme Inhibitor Therapy and Periprocedural Myocardial Infarction in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02054390
- Acronym / sponsor ID
- ACEmetsend
- Conditions
- Metabolic Syndrome, Coronary Artery Disease
- Keywords
- Angiotensin converting enzyme inhibitor, inflammation, metabolic syndrome, myonecrosis, percutaneous coronary intervention, periprocedural myocardial injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Feb 2014 (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.
Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the present cohort study is to investigate whether ACEi therapy reduces the rate of periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention (PCI) among patients with metabolic syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metabolic syndorme (MS) was defined as the presence of 3 or more of these components: 1. high fasting glucose (fasting serum glucose ≥100 mg/dl or drug treatment for elevated blood glucose) 2. abdominal obesity (given as waist circumference >102 cm in men and >88 cm in women) 3. high blood pressure (>130/>85 mmHg or drug treatment for hypertension) 4. hypertriglyceridemia (serum triglycerides ≥150 mg/dl) 5. low high-density lipoprotein (HDL) cholesterol (<40 mg/dl in men and <50 mg/dl in women).
Key inclusion criteria (2 listed)
- metabolic syndrome
- elective percutaneous coronary intervention with angiographically successful stent implantation
Key exclusion criteria (7 listed)
- acute coronary events
- renal failure
- needed the use of IV glycoprotein IIb/IIIa receptor inhibitors were excluded
- left main coronary artery disease
- chronic total occlusion
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
Periprocedural myocardial injury (MI)
Time frame: 24 hours after (percutaneous coroary intervention) PCI
Periprocedural MI was defined as cardiac Troponin I release [5 times ULN] 24 hours after percutaneous coronary intervention
1 secondary outcome
Periprocedural myonecrosis
Time frame: 24 hours after PCI
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 20 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metabolic Syndrome and Coronary Artery Disease, run by Ankara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 20 Jun 2014. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
Periprocedural myocardial injury (MI) (time frame: 24 hours after (percutaneous coroary intervention) PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2014.