Clinical Trials

ISCHEMIA-Chronic Kidney Disease Trial

Rochester, MN

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ISCHEMIA-Chronic Kidney Disease Trial

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis). This is a multicenter randomized controlled trial with a target randomization of ~1000 patients with advanced CKD and at least moderate ischemia on stress testing. Participants will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. The trial is designed to run seamlessly in parallel to the main ISCHEMIA trial as a companion ancillary trial. SPECIFIC AIMS A. Primary Aim. The primary aim of the ISCHEMIA-CKD trial is to determine whether an invasive strategy of routine early catheterization followed by optimal revascularization, in addition to OMT, will reduce the primary composite endpoint of death or nonfatal myocardial infarction in SIHD patients with advanced CKD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for those who fail OMT. The primary endpoint is time to centrally adjudicated death or nonfatal myocardial infarction (MI). B. Secondary Aims. Major: To compare angina-related quality of life between the INV and CON strategies. Other secondary aims include: comparing the incidence of the composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure; composite of cardiovascular death or nonfatal myocardial infarction; cardiovascular death; non-fatal myocardial infarction; all-cause death; stroke; hospitalization for heart failure or unstable angina Condition: Coronary Disease Procedure: Cardiac catheterization Phase: Phase III Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 16-008458
NCT ID:
NCT01985360
Sponsor Protocol Number:
U01HL117905

A Study of Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

Jacksonville, FL

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A Study of Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The primary purpose of this study is to test the theory that Eliquis (apixaban) is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 19-000517
NCT ID:
NCT03192215
Sponsor Protocol Number:
AAAR4607

TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

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Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Rochester, MN

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Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 16-007106
NCT ID:
NCT02675244
Sponsor Protocol Number:
GCO 08-1078-0010

A Study Relating Voice Characteristics and Cardiovascular Disease / Pulmonary Hypertension

Rochester, MN

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A Study Relating Voice Characteristics and Cardiovascular Disease / Pulmonary Hypertension

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to see if a new voice signal recording software program, can find a connection between abnormal voice signals and the presence and severity of cardiovascula disease / Pulmonary Hypertenison.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 14-000058
Sponsor Protocol Number:
14-000058

A Study to Evaluate the Effectiveness and Safety of D-PLEX in the Prevention of Sternal Infection Post- Cardiac Surgery

Rochester, MN

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A Study to Evaluate the Effectiveness and Safety of D-PLEX in the Prevention of Sternal Infection Post- Cardiac Surgery

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to assess the effectiveness and safety of D-PLEX administered concomitantly over a period of 90 days (3 months)with the standard of care (SOC) IV prophylactic antibiotic treatment vs. SOC in prevention of post-cardiac surgery sternal infections.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 19-006469
NCT ID:
NCT03558984
Sponsor Protocol Number:
D-PLEX 302

Physiologic Effects of Sleep Restriction

Rochester, MN

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Physiologic Effects of Sleep Restriction

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 11-002121
NCT ID:
NCT01433315
Sponsor Protocol Number:
11-002121

A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

Rochester, MN

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A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis. Secondary and tertiary objectives are to determine whether Ataciguat slows progression of aortic valve function, reduces systemic inflammation, and prevents left ventricular dysfunction in patients with moderate calcific aortic valve stenosis.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 14-006469
NCT ID:
NCT02481258
Sponsor Protocol Number:
14-006469

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Scottsdale/Phoenix, AZ

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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Scottsdale/Phoenix, Arizona: 14-008233
NCT ID:
NCT02089217
Sponsor Protocol Number:
CREST-2

Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term

Rochester, MN

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Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

ADAPTABLE is a pragmatic clinical trial in which 20,000 patients who are at high risk for ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81 mg/day vs. 325 mg/day. Study participants will be enrolled over 24 months. Maximum follow-up will be 30 months. The purpose of the study is to identify the optimal dose of aspirin for secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The primary endpoint is a composite of all-cause death, hospitalization for MI, or hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding with an associated blood product transfusion.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 17-006511
NCT ID:
NCT02697916
Sponsor Protocol Number:
17-006511

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Search Results 91-100 of 302 for heart disease

ISCHEMIA-Chronic Kidney Disease Trial

A Study of Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

A Study Relating Voice Characteristics and Cardiovascular Disease / Pulmonary Hypertension

A Study to Evaluate the Effectiveness and Safety of D-PLEX in the Prevention of Sternal Infection Post- Cardiac Surgery

Physiologic Effects of Sleep Restriction

A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term

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