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Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus (PROGRESSION)

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ClinicalTrials.gov Identifier: NCT03890822
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Giulio Stefanini, Humanitas Hospital, Italy

Brief 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. 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:

  1. 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;
  2. 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.

Condition or disease
Coronary Artery Disease Diabetes Mellitus

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : March 25, 2022
Estimated Study Completion Date : March 25, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentual atheroma volume [ Time Frame: 12 months ]
    Assessed by CT

  2. Minimal lumen area [ Time Frame: 12 months ]
    Assessed by CT


Secondary Outcome Measures :
  1. Percentual change in 18FNaF uptake [ Time Frame: 12 months ]
  2. Change in minimal lumen area [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with non-ST-segment elevation acute coronary syndrome, with or without diabetes mellitus
Criteria

Inclusion Criteria:

  • Age >18 and <80 years, evidence of non-ST-segment elevation acute coronary syndromes, ability to provide informed consent

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890822


Contacts
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Contact: Giulio Stefanini, MD, PhD, MSc +390282247384 giulio.stefanini@hunimed.eu
Contact: Gennaro Petriello, MD +390282247007 gennaro.petriello@humanitas.it

Locations
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Italy
Humanitas Research Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Giulio Stefanini, MD, PhD, MSc         
Contact: Gennaro Petriello, MD         
Sponsors and Collaborators
Humanitas Hospital, Italy
Investigators
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Study Chair: Giulio Stefanini, MD, PhD, MSc Humanitas Research Hospital IRCCS
Additional Information:

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Responsible Party: Giulio Stefanini, Head of Clinical Research, Cardio Center, Humanitas Hospital, Italy
ClinicalTrials.gov Identifier: NCT03890822    
Other Study ID Numbers: PROGRESSION
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Diabetes Mellitus
Disease Progression
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes