Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044213
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2002-08-22
Brief Title:
Trial to Assess Chelation Therapy TACT
Sponsor:
Mt Sinai Medical Center Miami
Organization:
Mt Sinai Medical Center Miami
Study Overview
Official Title:
Trial to Assess Chelation Therapy TACT
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic EDTA chelation therapy in individuals with coronary artery disease
Detailed Description:
EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system
Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo The primary endpoint of this trial will be a composite of all cause mortality myocardial infarction stroke coronary revascularization and hospitalization for angina
The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based
Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo The primary endpoint of this trial will be a composite of all cause mortality myocardial infarction stroke coronary revascularization and hospitalization for angina
The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL092607 | NIH | None | None |
| U01AT001156 | NIH | None | httpsreporternihgovquickSearchU01AT001156 |