Metal Allergy In-Stent Restenosis Study

Coronary Artery Disease Clinical Trial

— RESTALL  

Official title:

RESTenosis in Patients With Contact ALLergy to Metals Zabrze Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03588962
• Other study ID #: RESTALL Zabrze Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2018
• Source: Silesian Centre for Heart Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Introduction:

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. Although the proper stent expansion depends mostly on the cardiologist's manual dexterity, the inflammation development does totally not depend on the operator. The allergic reactions to metals are likely to be one of the underlying causes of inflammation. Among the most prevalent allergens, cobalt, chromium, nickel, and tungsten used as the stent materials are causing the most intensive contact allergic reaction. The allergic process induced by the aforementioned metals belongs to type IV contact allergy (T-cell mediated). Stent implantation results in life-long contact with metal, thus in allergic patients, it is likely to develop local reactions leading to in-stent restenosis. Up to date, there have been approximately one thousand in-stent restenosis cases documented in patients with confirmed contact allergy to stent metals.

Study objectives:

Analysis of the possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence.

Materials and methods:

The study will consist of two arms:

First arm: Patch tests for the metals used in stent production will be applicated in the patients with angiographically proven in-stent restenosis developed after technically correct implantation.

Second arm: In patients with (technically correctly) implanted stent, patch tests will be applicated to identify cases with contact allergy. The patients will then be monitored for a 6-12 months follow-up period in purpose of evaluating the dependance between in-stent restenosis and contact allergy.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• angiographically proven in-stent restenosis after technically correct implantation

• technically correctly implanted stent

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Contact Allergy
• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Dermatitis, Allergic Contact
• Hypersensitivity
• In-stent Restenosis
• Metal Allergy
• Myocardial Ischemia
• Restenoses, Coronary

Intervention

Biological:
• In-stent restenosis
Patch tests for the metals applicated in each of the patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events (MACE)	In-stent restenosis, acute myocardial infarction (AMI), death, cardiovascular (CV) death	12 months