Trial to Assess Chelation Therapy in Critical Limb Ischemia (TACT3a)
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|ClinicalTrials.gov Identifier: NCT03982693|
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia Diabetes||Drug: Edetate Disodium Other: Placebo||Phase 3|
TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk diabetic patients.
The study plans to enroll 50 patients with diabetes and critical limb ischemia (CLI) to prevent the major cardiovascular endpoints of major amputation, coronary revascularization, stroke, Myocardial Infarction (MI), or death (all-cause) during an average 1.25 years of follow-up. Patients will be randomly assigned to chelation or placebo with a 3:2 (30 active, 20 placebo) allocation ratio. Treatment will consist of 40 active or placebo infusions over 30 weeks. Active therapy will be the same edetate disodium-based infusion used safely and successfully in a previous published study, Trial to Assess Chelation Therapy (TACT). Baseline and post infusion urine metals will be collected. Following the final infusion, patients will be contacted quarterly until the end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Trial to Assess Chelation Therapy in Critical Limb Ischemia|
|Actual Study Start Date :||March 19, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||March 2022|
Active Comparator: Active
edetate disodium (EDTA)dff active infusion
Drug: Edetate Disodium
The solution contains up to 3 g of edetate disodium adjusted based on creatinine clearance, 2 g of magnesium chloride, 100 mg of procaine hydrochloride, 2500 U of heparin, 7 g of ascorbate, 2 milliequivalent (mEq) potassium chloride (KCl), 840 mg sodium bicarbonate, 250 mg pantothenic acid, 100 mg of thiamine, 100 mg of pyridoxine, and sterile water to complete 500 mL.
Other Name: TACT EDTA infusion
Placebo Comparator: Placebo
Placebo infusions consist of 500 ml normal saline.
- Prevention of major cardiovascular endpoints [ Time Frame: 3 years (average follow-up 1.25 years) ]Major cardiovascular endpoints include: coronary revascularization, stroke, MI, death (all-cause), or major amputation
- Amputations [ Time Frame: 3 years (average follow-up 1.25 years) ]
- Major amputations due to vascular disease. Major amputations are defined as any procedure that results in amputation at the level above the ankle. 49, 50
- Total amputations due to vascular disease
- Heart failure [ Time Frame: 3 years (average follow-up 1.25 years) ]• Heart failure hospitalizations or prolonged (>12 hours) ER stay for heart failure
- Changes in Pain severity [ Time Frame: 3 years (average follow-up 1.25 years) ]• Any changes in pain will be recorded at baseline, infusions 10, 20, 40 (or final), and end of study recorded using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference- Short Form 8a. The scale range is 1 to 5, with 1 being the best outcome (no pain interference) and 5 the worse (very much interference)
- Urine Metals [ Time Frame: 1 year ]• Changes in urine metal levels measured at the Metals Core Lab and measured at baseline and infusion 40 (or final).
- Changes in Quality of Life [ Time Frame: 3 years (average follow-up 1.25 years) ]• Health-related quality of life (QOL) changes recorded at baseline, 10, 20, 40 (or final), and end of study using the 36-Item Short Form Health Survey (SF-36 v2). The 36 questions assess eight health-related concepts: physical functioning, role limitations due to physical health problems (role physical), bodily pain, general health, energy levels/fatigue (vitality), social functioning, role limitations due to emotional problems (role emotional), and psychological distress (mental health). The scales vary depending on the question asked.The survey will be used to detect change (better or worse) in participants' health state over the course of the study.
- Wound Severity [ Time Frame: 3 years (average follow-up 1.25 years) ]Wound severity (quantified and imaged with HIPAA-compliant photography) photographed at baseline 10, 20, 40 (or final), and end of study
- Changes in skin perfusion pressure in the ankle [ Time Frame: 3 years (average follow-up 1.25 years) ]• Changes in skin perfusion pressure will be measured at 10, 20, 40 (or final), and end of study, using the ankle-brachial index (mmHg)
- Changes in skin perfusion pressure in the toe [ Time Frame: 3 years (average follow-up 1.25 years) ]• Changes in skin perfusion pressure will be measured at 10, 20, 40 (or final), and end of study, using the toe-brachial index (mmHg).
- Changes in PAD Quality of Life [ Time Frame: 3 years (average follow-up 1.25 years) ]• PAD related quality of life (QOL) changes recorded at baseline, 10, 20, 40 (or final), and end of study using the Peripheral Artery Questionnaire (PAQ), which is a 20-item questionnaire measuring physical limitations, symptoms, symptom stability, treatment satisfaction, quality of life, and social function. The scales vary depending on the question asked. The survey will be used to detect change (better or worse) in participants responses over the course of the study.
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): NCT03982693
|Contact: Francisco Ujueta, MD||305-674-2162||Francisco.Ujueta@msmc.com|
|Contact: Beatriz Acevedo||305-674-2162||Beatriz.Acevedo@msmc.com|
|United States, Florida|
|Mount Sinai Medical Center||Recruiting|
|Miami Beach, Florida, United States, 33140|
|Contact: Francisco Ujueta, MD 305-674-2162 Francisco.Ujueta@msmc.com|
|Contact: Beatriz Acevedo 305-674-2162 Beatriz.Acevedo@msmc.com|
|Principal Investigator:||Gervasio Lamas, MD||Icahn School of Medicine at Mount Sinai|