Metal Allergy In-Stent Restenosis Study

NCT03588962 | Unknown

• 1 other identifier: RESTALL Zabrze Study
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation. There are multiple factors causing restenosis, which can be divided into two major groups: first vessel-dependent (based on the vessel's tortuosity, dimensions and lesion's calcification, all leading to suboptimal stent expansion), and second dependent on the inflammatory processes caused by the intervention. Study objectives is the analysis of the possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence. The angiographic results of stent implantation, and in-stent restenosis will be assessed independently by two skilled interventional cardiologists, and in case of their discrepant opinions, the decision will be made on the basis of the third cardiologist. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.

Conditions

Metal Allergy; Contact Allergy; Restenoses, Coronary; In-stent Restenosis; Coronary Artery Disease

Keywords

allergy to metals, restenosis, in-stent restenosis; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  In-stent restenosis, acute myocardial infarction (AMI), death, cardiovascular (CV) death

  12 months

Study Arms (2)

Metal allergy driven restenosis

EXPERIMENTAL

Patients with angiographically proven in-stent restenosis developed after technically correct implantation. Patch tests for the metals used in stent production will be applicated. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards. Possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence.

Biological: In-stent restenosis

Looking for allergic restenosis

PLACEBO COMPARATOR

Patients with (technically correctly) implanted stent. Patch tests will be applicated to identify cases with contact allergy. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.The patients will then be monitored for a 12 months follow-up period in purpose of evaluating the dependance between in-stent restenosis and contact allergy. Possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence.

Biological: In-stent restenosis

Interventions

In-stent restenosis BIOLOGICAL

Patch tests for the metals applicated in each of the patients

Looking for allergic restenosis; Metal allergy driven restenosis

Eligibility Criteria

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

You may qualify if:

• angiographically proven in-stent restenosis after technically correct implantation
• technically correctly implanted stent

You may not qualify if:

• autoimmune diseases (e.g., rheumatoid arthritis)
• immunodeficiency syndromes (e.g., HIV infection)
• chronic use of immunosuppressive drugs and/or corticosteroids
• skin lesions that may attenuate the reading of skin tests
• previous coronary artery bypass surgery (in subgroup 1) or planned coronary artery bypass surgery (in subgroup 2)
• any surgical procedure with metal implants (in the past or planned within 12 months of observation)

Sponsors & Collaborators

• Silesian Centre for Heart Diseases: lead

MeSH Terms

Conditions

Dermatitis, Allergic Contact; Coronary Restenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Head of III Dept. of Cardiology

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: July 17, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: December 31, 2020
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share