Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support (MedaMACS)
MedaMACS is a prospective, observational study of ambulatory patients with advanced heart failure. The study enrolls patients who have not yet received a Left Ventricular Assist Device (LVAD) but who receive their care at a hospital with a Joint Commission certified mechanical circulatory support program.
MedaMACS is funded through the Interagency for Mechanically Assisted Circulatory Support (INTERMACS) NHLBI Contract.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support|
- Survival rate of participants who did not receive ventricular assist device (VAD) implantation [ Time Frame: Measured through 24 months. ] [ Designated as safety issue: No ]Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.
- Survival rate of participants who received VAD implantation [ Time Frame: Measured through 24 months. ] [ Designated as safety issue: No ]Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.
- Survival rate of participants who did not receive heart transplantation [ Time Frame: Measured through 24 months ] [ Designated as safety issue: No ]Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.
- Survival rate of participants who received heart transplantation [ Time Frame: Measured through 24 months ] [ Designated as safety issue: No ]
- Events [ Time Frame: Measured through 24 months. ] [ Designated as safety issue: No ]Events (hospitalization, heart transplantation, VAD, death, infection, neurologic, bleeding) will be collected at baseline and at 6 month intervals for 24 months.
- Quality of Life [ Time Frame: Measured through 24 months. ] [ Designated as safety issue: No ]Quality of life measures will be collected at baseline and at 6 month intervals for 24 months.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
All participants who have met the inclusion criteria.
Other: No Intervention
MedaMACS does not provide intervention or therapy. MedaMACS collects data of routine medical care for patients with advanced heart failure who do not receive a mechanical circulatory support device.
Participants between 18 and 80 years old with low ejection fraction history and hospitalization for heart failure within the past year will be screened for the study. All subjects who have been admitted to the heart failure service will be screened and recruited, either as an inpatient or during their first outpatient follow-up appointment by the investigator and research staff caring for patients in the advanced heart failure program.
Eligibility for enrollment will be based only upon information that is clinically available at the time of screening. The history of prior hospitalizations will be available from clinical records.
Routine evaluation and triage of ambulatory patients with advanced heart disease includes echocardiography and functional assessment with peak oxygen consumption and frequently 6 minute walk distance. The elements of information required for estimation of the Seattle Heart Failure Risk score will be gleaned from laboratory data, or imputed as described in the Seattle score literature. The research coordinator will enter this data onto a currently available website for calculation of the Seattle score.
Eligibility will be determined by the inclusion and exclusion criteria and the study research team will approach individual subjects who are potential candidates for participation once the subject's primary physician has given permission to approach. Only persons with a scientific or ethical reason will be excluded. Incarcerated prisoners have been excluded by this protocol.
Participants will be followed every 6 months for 24 months after two baseline visits. The 6 month and 18 month follow ups consist of telephone interviews. Follow ups at 12 months and 24 months consists of routine clinical visits.
Approximately 350 patients from 12 centers in the United States will be enrolled over a 12 month period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01932294
|Contact: Sharmene Smithfirstname.lastname@example.org|
|Contact: Mary Lynne Clarkemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: David Baldwin firstname.lastname@example.org|
|Principal Investigator: Salpy Pamboukian, M.D.|
|United States, California|
|Cedars Sinai Medical Center||Recruiting|
|Beverly Hills, California, United States, 90211|
|Contact: Maria Thottam Maria.Thottam@cshs.org|
|Principal Investigator: Michelle Kittleson, M.D.|
|United States, Colorado|
|University of Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Christina Schmitt Christina.Schmitt@ucdenver.edu|
|Principal Investigator: Amrut Ambardekar, M.D.|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Cynthia Larew 319-353-7953 email@example.com|
|Principal Investigator: Linda Cadaret, MD|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Susan Anello 617-732-7174 firstname.lastname@example.org|
|Principal Investigator: Garrick Stewart, MD|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Joanna Wells 734-232-6383 email@example.com|
|Principal Investigator: Maryse Palardy, MD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Gayle Challinor 919-668-7184 firstname.lastname@example.org|
|Principal Investigator: Chetan Patel, MD|
|United States, Ohio|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Barbara Gus 216-445-6552 email@example.com|
|Principal Investigator: Maria Mountis, MD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Kimberly Clinton 215-662-2803 firstname.lastname@example.org|
|Principal Investigator: Eduardo Rame, M.D.|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Traci McGaha 412-647-5724 email@example.com|
|Principal Investigator: Jeffrey J Teuteberg, MD|
|United States, Texas|
|Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Lynn Fernandez 205-645-8040 firstname.lastname@example.org|
|Principal Investigator: Jennifer Thebodeau, M.D.|
|Principal Investigator:||James K Kirklin, MD||INTERMACS Principal Investigator|