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| Name | Class |
|---|---|
| Colorado Prevention Center | OTHER |
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Patients with peripheral artery disease have decreased blood flow to exercising muscle causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines which in turn decreases the level of carnitine. Carnitine allows muscles to function properly. This study will test the safety and efficacy of Propionyl-L-Carnitine taken in combination with a monitored exercise training program.
To test the hypothesis that Propionyl-L-Carnitine taken in combination with monitored exercise training may improve exercise performance the study will randomize male or female adults with peripheral artery disease and claudication to receive either Proprionyl-L-Carnitine or Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLC | Experimental | Investigational drug |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propionyl-L-Carnitine | Drug | 2 grams per day for six months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak walking time | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Claudication onset time, activity level and quality of life | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edgar Carell | Western Suburban Cardiologists, Ltd. | Principal Investigator |
| Kenneth Morris | Durham VA Medical Center | Principal Investigator |
| Bruce Cutler | University of Massachusetts, Worcester | Principal Investigator |
| Robert McLafferty | SIU School of Medicine | Principal Investigator |
| Richard Powell | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Layne Yonehiro | Baptist Clinical Research | Principal Investigator |
| Karl Illig | University of Rochester | Principal Investigator |
| William Abernethy | Asheville Cardiology Associates | Principal Investigator |
| Michael Koren | Jacksonville Center For Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States | ||
| Baptist Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33186199 | Derived | Mays RJ, Wesselman CW, White R, Creager MA, Amato A, Greenwalt M, Hiatt WR. Automated Detection of Exercise Sessions in Patients With Peripheral Artery Disease: EVIDENCE FOR AN EXERCISE DOSE RESPONSE TO TRAINING. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):176-181. doi: 10.1097/HCR.0000000000000553. | |
| 20861750 | Derived |
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| PLC |
| Drug |
2 grams/day for six months |
|
| Pensacola |
| Florida |
| 32501 |
| United States |
| Western Suburban Cardiologists, Ltd. | LaGrange | Illinois | 60525 | United States |
| SIU School of Medicine | Springfield | Illinois | 62702 | United States |
| University of Massachusetts Medical Center | Worchester | Massachusetts | 01655 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| University of Rochester Medical Center | Rochester | New York | 14618 | United States |
| Asheville Cardiology Associates | Asheville | North Carolina | 28803 | United States |
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
| Hiatt WR, Creager MA, Amato A, Brass EP. Effect of propionyl-L-carnitine on a background of monitored exercise in patients with claudication secondary to peripheral artery disease. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):125-32. doi: 10.1097/HCR.0b013e3181f1fd65. |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D007383 | Intermittent Claudication |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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