Progenitor Cells Role in Restenosis and Atherosclerosis

NCT01575431 | Completed

• 1 other identifier: 199/2012/D
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to prospectively investigate the relationship of circulating endothelial progenitor cells at time of percutaneous coronary intervention to the subsequent development of in-stent restenosis or progression of coronary atherosclerosis.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; endothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

• Results of the 1-year follow-up coronary angiography

  On the basis of the results of the 1-year follow-up coronary angiography, it will be possible to group patients in those with in-stent restenosis and those with progression of coronary atherosclerosis. Thereafter, numbers of endothelial progenitor cells at time of percutaneous coronary intervention will be compared between the two groups.

  Up to 1 year

Secondary Outcomes (2)

• Results of the 5-year clinical follow-up

  Up to 5 years

• Results of the 10-year clinical follow-up

  Up to 10 years

Study Arms (1)

Stable angina

Patients who undergo an elective and successful single or multivessel percutaneous coronary intervention can be considered for the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive patient sampling

You may qualify if:

• evidence of complete revascularization of clinically important stenoses by PCI
• willing to undergo 8-month control angiography.

You may not qualify if:

• in-hospital death after PCI
• myocardial infarction during follow-up to exclude potential subacute stent
• unstable angina
• any increase in creatine kinase-myocardial band, troponin I, myoglobin, or liver enzymes above upper normal limit before PCI
• left ventricular ejection fraction\<30%
• renal failure with creatinine\>2 mg/dl
• treatment with statins at referral

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

University La Sapienza

Rome, 00166, Italy

Location

Related Publications (2)

• Pelliccia F, Pasceri V, Moretti A, Tanzilli G, Speciale G, Gaudio C. Endothelial progenitor cells predict long-term outcome in patients with coronary artery disease: Ten-year follow-up of the PROCREATION extended study. Int J Cardiol. 2020 Nov 1;318:123-125. doi: 10.1016/j.ijcard.2020.06.002. Epub 2020 Jun 6.

  PMID: 32522679 DERIVED

• Pelliccia F, Pasceri V, Rosano G, Pristipino C, Roncella A, Speciale G, Pannarale G, Schiariti M, Greco C, Gaudio C. Endothelial progenitor cells predict long-term prognosis in patients with stable angina treated with percutaneous coronary intervention: five-year follow-up of the PROCREATION study. Circ J. 2013;77(7):1728-35. doi: 10.1253/circj.cj-12-1608. Epub 2013 Apr 11.

  PMID: 23575363 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Francesco Pelliccia, MD

  University La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 11, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

IT (1)