AtherosclerosisNCT01290770
Search a Correlation Between Lp(a) Rate and TFPI Activity in Obese Patients With Chest Pain Like Angina
An observational study of Atherosclerosis, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- blood sample
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2011to Apr 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: obese men with chest pain like stable angina
Who may be able to join
- Major
- Men
- Obese BMI>30
- No aspirin treatment before inclusion
- Coronary exploration: coronary angiography or tomography coronary angiography
- Chest pain like stable angina
Who cannot join
- Women
- Severe hepatic insufficiency
- Inflammatory disease
- Neoplasia
- Protein S deficiency
- Aspirin treatment 10 days before inclusion
- Oral anticoagulant treatment at inclusion
- Heparin or low molecular weight heparin treatment at inclusion
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de cardiologie - CHG Feurs
Feurs, 42110
Service de cardiologie - CHG Firminy
Firminy, 42700
Service de cardiologie - CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Search a Correlation Between Lipoprotein(a) Rate and TFPI(Tissue Factor Pathway Inhibitor)Activity in Obese Patients With Chest Pain Like Angina
Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is associated with an increase risk of cardiovascular complications.
Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is a risk factor for recurrent coronary events in obese patient.
Read more
Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .
The aim of this study is to research reverse association between Lp(a) and TFPI activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.
- Conditions
- Atherosclerosis
- Being tested
- blood sample
- Keywords
- obesity, men, TFPI, Lipoprotein(a), Lp(a), Tissue Factor pathway inhibitor, aspirin
- Medical subject headings
- Atherosclerosis, Obesity, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
blood sample at inclusion and 1 month after inclusion
| Study group | Role | What they receive |
|---|---|---|
| obese men | obese men with chest pain like angina Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between Lp(a) and TFPI activity
Establish correlation between Lp(a) rate and TFPI activity in obese patients with chest pain like stable angina
Measured: day 1
Secondary outcomes (4)
Correlation between Lp(a) and TFPI resistance
Establish correlation between Lp(a) rate and TFPI resistance at inclusion and 1 month after aspirin treatment
Measured: day 1
Correlation between lp(a) rate and TFPI activity
Establish the correlation, 1 month after initiation of aspirin treatment, between lp(a) rate and TFPI activity
Measured: 1 month
thrombin generation
describe thrombin generation with calibrated automated thrombinography technique in obese patient with chest pain like angina and hight Lp(a)rate
Measured: day 1
Correlation between Lp(a) and TFPI resistance
Establish correlation between Lp(a) rate and TFPI resistance at inclusion and 1 month after aspirin treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte TARDY, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290770
- Sponsor's protocol ID
- 1008178
- Status last verified
- Sep 2014
- First submitted
- 3 Feb 2011
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search a Correlation Between Lipoprotein(a) Rate and TFPI(Tissue Factor Pathway Inhibitor)Activity in Obese Patients With Chest Pain Like Angina
- ClinicalTrials.gov ID
- NCT01290770
- Acronym / sponsor ID
- 1008178
- Conditions
- Atherosclerosis
- Keywords
- obesity, men, TFPI, Lipoprotein(a), Lp(a), Tissue Factor pathway inhibitor, aspirin
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Feb 2011 (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.
Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is associated with an increase risk of cardiovascular complications.
Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is a risk factor for recurrent coronary events in obese patient.
Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .
The aim of this study is to research reverse association between Lp(a) and TFPI activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese men | – | Other: blood sampleobese men with chest pain like angina |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- obese men with chest pain like stable angina
Key inclusion criteria (6 listed)
- Major
- Men
- Obese BMI>30
- No aspirin treatment before inclusion
- Coronary exploration: coronary angiography or tomography coronary angiography
Key exclusion criteria (8 listed)
- Women
- Severe hepatic insufficiency
- Inflammatory disease
- Neoplasia
- Protein S deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleblood sample at inclusion and 1 month after inclusion | Other | obese men |
Primary outcome
correlation between Lp(a) and TFPI activity
Time frame: day 1
Establish correlation between Lp(a) rate and TFPI activity in obese patients with chest pain like stable angina
4 secondary outcomes
Correlation between Lp(a) and TFPI resistance
Time frame: day 1
Correlation between lp(a) rate and TFPI activity
Time frame: 1 month
thrombin generation
Time frame: day 1
Correlation between Lp(a) and TFPI resistance
Time frame: 1 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
Brigitte TARDY, MD principal investigator
CHU de Saint-Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 was stopped early. 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?
correlation between Lp(a) and TFPI activity (time frame: day 1). 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 29 Sep 2014.