Atherosclerosis, Coronary Clinical Trial
Official title:
A Phase 1, Feasibility Study Testing the Safety and Feasibility of Intracoronary CD34+ Cell Administration on Coronary Endothelial Function in Patients With Early Coronary Atherosclerosis
Verified date | February 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
How safe and effective are CD34+ cell intracoronary injections for treating coronary endothelial dysfunction (CED)?
Status | Completed |
Enrollment | 21 |
Est. completion date | October 2, 2020 |
Est. primary completion date | October 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Diagnosis of coronary endothelial dysfunction based on coronary angiogram and acetylcholine comprehensive coronary physiology study - Able to provide informed written consent and willing to participate in all required study follow-up assessments Exclusion Criteria: - Acute coronary syndrome or continuous/ongoing chest pain - unremitting and unresponsive to nitroglycerin or rest - persisting 4 or more days before stent placement. If the chest pain syndrome is transient and/or intermittent - even if it began more than 3 days prior to admission - the patient is not excluded. - Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible. - Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel, ticlopidine,prasugrel, etc). - Abnormal laboratory values (Hgb <11 mg/dL; glomerular filtration rate (GFR)<50; liver function tests (LFTs)>2x upper limit of normal). - Subjects receiving warfarin who have an international normalized ratio (INR) >2 at the end of the screening phase or with major bleeding requiring active transfusion support. - Subjects with severe cardiac valvular disease expected to undergo surgery within 1 year. - Subjects with known severe immunodeficiency states (AIDS). - Significant coronary artery disease on coronary angiogram - Cirrhosis requiring active medical management. - Malignancy requiring active treatment (except basal cell skin cancer). - Subjects with documented active alcohol and /or other substance abuse. - Females of child bearing potential unless a pregnancy test is negative within 7 days of the bone marrow harvest. - Re-occlusion of the infarct related artery (IRA) prior to the infusion procedure. - Planned revascularization intervention during the next 6 months. (A second PCI can be performed if done prior to qualifying cardiovascular magnetic resonance imaging (CMR) at least 96 hours post primary PCI). - Participation in an ongoing investigational trial. - Active or suspected bacterial infection requiring systemic intravenous antibiotics. - Additional factors deemed unsuitable for trial enrollment per discretion of principal investigator - Inmates |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects experiencing adverse events | 12 months | ||
Primary | Number of subjects experiencing serious adverse events | 12 months | ||
Primary | Number of subjects experiencing Major Adverse Cardiovascular Events (MACE) | The most commonly reported major cardiovascular adverse events (MACE) include myocardial infarction, heart failure, percutaneous cardiac intervention, coronary artery bypass grafting, malignant dysrhythmia, cardiac shock, implantable cardiac defibrillator, malignant dysrhythmia and death. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03427996 -
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
|
||
Not yet recruiting |
NCT04762472 -
Air Pollution (PM2.5) on Accelerated Atherosclerosis: A Montelukast Interventional Study in Modernizing China
|
Phase 4 | |
Not yet recruiting |
NCT03174418 -
Fluid-dynamics in Bifurcation PCI
|
N/A | |
Not yet recruiting |
NCT03813017 -
Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05600088 -
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina
|
N/A | |
Completed |
NCT03011775 -
Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease
|
Phase 4 | |
Completed |
NCT00115583 -
The Contribution of Endothelin to Vasomotor Function in Diseased Coronary Arteries
|
N/A | |
Completed |
NCT03149042 -
Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
|
||
Not yet recruiting |
NCT05540223 -
Safety and Clinical Performance of the DREAMS 3G Resorbable Magnesium Scaffold System
|
N/A | |
Completed |
NCT02389946 -
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
|
N/A | |
Completed |
NCT01234870 -
Comprehensive Evaluation of Ischemic Heart Disease Using MRI
|
Phase 2/Phase 3 | |
Completed |
NCT00353795 -
Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)
|
N/A | |
Enrolling by invitation |
NCT04810364 -
HIV Infection And Evolvement of Atherosclerotic Plaque
|
||
Active, not recruiting |
NCT04175626 -
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
|
||
Recruiting |
NCT00146887 -
Comparison of Coronary CT Angiography to Invasive Coronary Angiography
|
N/A | |
Completed |
NCT05492084 -
Personalized Risk of Rapidly Progressive Atherosclerosis
|
||
Recruiting |
NCT04853511 -
Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability
|
||
Completed |
NCT03815032 -
Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison
|
N/A | |
Active, not recruiting |
NCT03129503 -
Optical Coherence Tomography in Acute Coronary Syndrome
|
||
Recruiting |
NCT06393894 -
Latvian Early Atherosclerosis Registry
|