Coronary Artery DiseasePROGRESSIONNCT03890822
Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus
An observational study of Coronary Artery Disease and Diabetes Mellitus, run by Humanitas Hospital, Italy at 1 site in Italy.
Trial summary
A total of 100 patients with non-ST-segment elevation acute coronary syndromes with or without diabetes mellitus will be included. All patients will undergo coronary angiography with identification of the infarct-related vessel and percutaneous revascularization with implantation of a stent/scaffold. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2019to 25 Mar 2022
- How long will I take part?
- 12 Months
- 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: Patients with non-ST-segment elevation acute coronary syndrome, with or without diabetes mellitus
Who may be able to join
- Age >18 and <80 years, evidence of non-ST-segment elevation acute coronary syndromes, ability to provide informed consent
Who cannot join
- ST-segment elevation myocardial infarction, cardiogenic shock, suspected stent thrombosis, known allergy to aspirin or ticagrelor, childbearing potential, life expectancy <1 year due to non-cardiac disease, severe chronic kidney disease.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, Milan, 20089
Giulio Stefanini, MD, PhD, MSc
Gennaro Petriello, MD
About this study
A total of 100 patients with non-ST-segment elevation acute coronary syndromes with or without diabetes mellitus will be included. All patients will undergo coronary angiography with identification of the infarct-related vessel and percutaneous revascularization with implantation of a stent/scaffold. After revascularization patients will undergo a combined positron emission tomography (PET)-coronary computed tomography (CT) protocol to quantify atherosclerotic burden (i.e. plaque volume) and activity (i.e. 18 fluorum-sodium-fluoride [18FNaF] uptake) in non-infarct related vessels, to assess calcium score (aim 1), and to quantify the acute results of PCI in the infarct-related vessel (aim 2). At 12-month follow-up, all patients will repeat longitudinal 18FNaF PET-coronary CT evaluation to characterize progression of atherosclerosis in the non-infarct related vessels (aim 1) and to quantify neointimal suppression at the site of the treated coronary segment in the infarct-related vessel (aim 2). Blood samples will be collected at baseline and 12 months for all patients.
The aims of the study are:
- To evaluate coronary artery disease progression in acute coronary syndromes patients with and without diabetes mellitus, and to investigate the predictive value of metabolic profiles, patterns of circulating miRNAs and inflammatory mediators on coronary artery disease progression;
- To evaluate the progression of disease within the infarct-related vessel treated with the use of bioresorbable stent/bioresorbable polymer stents in diabetic and non-diabetic patients with acute coronary syndromes.
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentual atheroma volume
Assessed by CT
Measured: 12 months
Minimal lumen area
Assessed by CT
Measured: 12 months
Secondary outcomes (2)
Percentual change in 18FNaF uptake
Measured: 12 months
Change in minimal lumen area
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start25 Mar 2019
- Primary completion25 Mar 2022 (estimated)
- Study completion25 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Humanitas Hospital, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Stefanini, Humanitas Hospital, Italy
- Investigators
- Giulio Stefanini, MD, PhD, MSc, Study chair, Humanitas Research Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890822
- Sponsor's protocol ID
- PROGRESSION
- Acronym
- PROGRESSION
- Status last verified
- May 2019
- First submitted
- 23 Mar 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03890822
- Acronym / sponsor ID
- PROGRESSION / PROGRESSION
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Humanitas Hospital, ItalyUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 Mar 2022 (estimated)
- Study completion
- 25 Mar 2022 (estimated)
- First posted
- 26 Mar 2019 (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.
A total of 100 patients with non-ST-segment elevation acute coronary syndromes with or without diabetes mellitus will be included. All patients will undergo coronary angiography with identification of the infarct-related vessel and percutaneous revascularization with implantation of a stent/scaffold. After revascularization patients will undergo a combined positron emission tomography (PET)-coronary computed tomography (CT) protocol to quantify atherosclerotic burden (i.e. plaque volume) and activity (i.e. 18 fluorum-sodium-fluoride [18FNaF] uptake) in non-infarct related vessels, to assess calcium score (aim 1), and to quantify the acute results of PCI in the infarct-related vessel (aim 2). At 12-month follow-up, all patients will repeat longitudinal 18FNaF PET-coronary CT evaluation to characterize progression of atherosclerosis in the non-infarct related vessels (aim 1) and to quantify neointimal suppression at the site of the treated coronary segment in the infarct-related vessel (aim 2). Blood samples will be collected at baseline and 12 months for all patients.
The aims of the study are:
- To evaluate coronary artery disease progression in acute coronary syndromes patients with and without diabetes mellitus, and to investigate the predictive value of metabolic profiles, patterns of circulating miRNAs and inflammatory mediators on coronary artery disease progression;
- To evaluate the progression of disease within the infarct-related vessel treated with the use of bioresorbable stent/bioresorbable polymer stents in diabetic and non-diabetic patients with acute coronary syndromes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-ST-segment elevation acute coronary syndrome, with or without diabetes mellitus
Key inclusion criteria (1 listed)
- Age >18 and <80 years, evidence of non-ST-segment elevation acute coronary syndromes, ability to provide informed consent
Key exclusion criteria (1 listed)
- ST-segment elevation myocardial infarction, cardiogenic shock, suspected stent thrombosis, known allergy to aspirin or ticagrelor, childbearing potential, life expectancy <1 year due to non-cardiac disease, severe chronic kidney disease.
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
Percentual atheroma volume
Time frame: 12 months
Assessed by CT
Minimal lumen area
Time frame: 12 months
Assessed by CT
2 secondary outcomes
Percentual change in 18FNaF uptake
Time frame: 12 months
Change in minimal lumen area
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
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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.
Giulio Stefanini, MD, PhD, MSc study chair
Humanitas Research Hospital IRCCS
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 Artery Disease and Diabetes Mellitus, run by Humanitas Hospital, Italy 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 1 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: status not confirmed, as of the sponsor's last update on 7 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulio Stefanini, MD, PhD, MSc (+390282247384, giulio.stefanini@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentual atheroma volume (time frame: 12 months). The study lists 2 primary outcomes in all. 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 7 May 2019.