Ischemic Heart DiseaseNCT05574621
ITA Vs LAD; Evaluation of Inflammatory Burden in OP-CABG Patients
An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial summary
Introduction. Ischemic cardiomyopathy is one of the death leading causes in industrialized countries. Up-to-date ESC guidelines recommend a surgical approach (coronary by pass graft) in patients with multivessel coronaropathy, with involvement of left main (LM) or proximal left anterior descending (LAD) artery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Disease, Atherosclerosis
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 1 Mar 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited among the all-comers surgical candidates at European Hospital of Rome, which includes out patient clinic, internal transfers from cardiology unit, urgent transfers from other regional hospitals.
Who may be able to join
- Scheduled coronary bypass surgery
- Off-pump procedure
- ITA-LAD anastomosis
Who cannot join
- STEMI in the last month
- LVEF > 30%
- LAD chronic occlusion
- Acute or chronic inflammatory diseases
- Immunologic or rheumatic diseases
- Oncologic condition (present or in the last 3 years)
- Active infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Inflammatory Markers, Oxidative Stress, Platelet Activation and Autophagy Between Internal Thoracic Artery and Left Anterior Descending Artery in Patients Subjected to Off-pump Surgical Myocardial Revascularization
Introduction. Ischemic cardiomyopathy is one of the death leading causes in industrialized countries. Up-to-date ESC guidelines recommend a surgical approach (coronary by pass graft) in patients with multivessel coronaropathy, with involvement of left main (LM) or proximal left anterior descending (LAD) artery. In any case, is recommended the use of the internal thoracic artery (ITA) as conduct of choice.
In consideration of the very strong evidence supporting the use of ITA, the study objective is to analyze and compare some blood markers collected from ITA blood vs. LAD blood, with the purpose of better understanding the technique benefits from a biological point of view, being the hemodynamic one already evident.
Read more
Methods. Forty patients scheduled for coronary bypass graft (CABG) surgery at the Cardiac Surgery Unit of European Hospital of Rome will be enrolled. Patients which intervention includes off-pump ITA-LAD anastomosis will be included. For each patient blood sample from ITA and LAD will be collected. On those samples, polymorphonuclear leukocytes and platelets activity, endothelial dysfunction, oxidative stress and inflammatory burden will be analysed. In patients in which a pre-operative coronary CT scan is available, findings will be correlated with atherosclerotic plaque morphology.
Expected results. Diseased LAD's blood will have a deranged markers profile compared with ITA's, with augmented inflammatory burden, reduce NO availability and increased platelet activation. In the patients subgroup with available coronary CT scan will be possible to esteem the effective blood mixing and speculate on a possible pharmacological effect of CABG, in terms of dilution of inflammatory burden in the target vessel.
- Keywords
- coronary artery bypass graft, coronary revascularization
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Atherosclerosis, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory burden
Serum inflammatory cytokines, evaluated through enzyme-linked immunosorbent assays (ELISA)
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Oxidative stress
soluble NOX-derived peptide evaluated through ELISA; H2O2 evaluated with colorimetric test
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Jul 2021
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, Andrea Salica, Francesco Giosuè Irace
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574621
- Sponsor's protocol ID
- EH2021-01
- Status last verified
- Sep 2023
- First submitted
- 1 Oct 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inflammatory Markers, Oxidative Stress, Platelet Activation and Autophagy Between Internal Thoracic Artery and Left Anterior Descending Artery in Patients Subjected to Off-pump Surgical Myocardial Revascularization
- ClinicalTrials.gov ID
- NCT05574621
- Acronym / sponsor ID
- EH2021-01
- Keywords
- coronary artery bypass graft, coronary revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Collaborators
- University of Roma La Sapienza, Andrea Salica, Francesco Giosuè Irace
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- 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.
Introduction. Ischemic cardiomyopathy is one of the death leading causes in industrialized countries. Up-to-date ESC guidelines recommend a surgical approach (coronary by pass graft) in patients with multivessel coronaropathy, with involvement of left main (LM) or proximal left anterior descending (LAD) artery. In any case, is recommended the use of the internal thoracic artery (ITA) as conduct of choice.
In consideration of the very strong evidence supporting the use of ITA, the study objective is to analyze and compare some blood markers collected from ITA blood vs. LAD blood, with the purpose of better understanding the technique benefits from a biological point of view, being the hemodynamic one already evident.
Methods. Forty patients scheduled for coronary bypass graft (CABG) surgery at the Cardiac Surgery Unit of European Hospital of Rome will be enrolled. Patients which intervention includes off-pump ITA-LAD anastomosis will be included. For each patient blood sample from ITA and LAD will be collected. On those samples, polymorphonuclear leukocytes and platelets activity, endothelial dysfunction, oxidative stress and inflammatory burden will be analysed. In patients in which a pre-operative coronary CT scan is available, findings will be correlated with atherosclerotic plaque morphology.
Expected results. Diseased LAD's blood will have a deranged markers profile compared with ITA's, with augmented inflammatory burden, reduce NO availability and increased platelet activation. In the patients subgroup with available coronary CT scan will be possible to esteem the effective blood mixing and speculate on a possible pharmacological effect of CABG, in terms of dilution of inflammatory burden in the target vessel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited among the all-comers surgical candidates at European Hospital of Rome, which includes out patient clinic, internal transfers from cardiology unit, urgent transfers from other regional hospitals.
Key inclusion criteria (3 listed)
- Scheduled coronary bypass surgery
- Off-pump procedure
- ITA-LAD anastomosis
Key exclusion criteria (7 listed)
- STEMI in the last month
- LVEF > 30%
- LAD chronic occlusion
- Acute or chronic inflammatory diseases
- Immunologic or rheumatic diseases
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
Inflammatory burden
Time frame: through study completion, an average of 6 months
Serum inflammatory cytokines, evaluated through enzyme-linked immunosorbent assays (ELISA)
1 secondary outcome
Oxidative stress
Time frame: through study completion, an average of 6 months
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 21 Sep 2023.
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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 Ischemic Heart Disease and Coronary Artery Disease, run by Cardiochirurgia E.H. 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 3 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 21 Sep 2023. 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.
What does the primary outcome measure?
Inflammatory burden (time frame: through study completion, an average of 6 months). 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 21 Sep 2023.