Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005928
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-06-28
Brief Title:
Effects of Angiotensin-Converting Enzyme Inhibitor Ramipril Therapy on Blood Vessel Inflammation
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Angiotensin Converting Enzyme Inhibitor Therapy on Vascular Inflammation and Compliance
Status:
COMPLETED
Status Verified Date:
2002-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effects of angiotensin-converting enzyme ACE inhibitor trade name Ramipril therapy on inflammation and stiffness of artery walls These are two risk factors for developing atherosclerosis-deposits of fatty substances called plaques that can block the blood vessel causing a heart attack or stroke Studies of patients with coronary artery disease suggest that ACE inhibitor therapy reduces the risk of heart attack and heart failure This study will examine the effects of this treatment on the artery walls and on levels of substances in the blood that indicate blood vessel inflammation
Patients between 40 and 75 years old with coronary artery disease caused by atherosclerosis may be eligible for this study Candidates will be screened with a medical history cardiovascular heart and blood vessel examination electrocardiogram and blood tests Those enrolled will be randomly assigned to take either an ACE inhibitor pill or a placebo look-alike pill with no medicine once a day for 3 months No pills will be taken for the next month and then participants will take the alternate pill for the next 3 months That is those who took ACE inhibitor for the first 3-month period will take placebo for the second 3-month period and vice versa Blood pressures will be taken at the NIH Clinical Center or by the patients physician at the end of the first and second weeks of the study At the end of 3 weeks patients will return to the Clinical Center for a blood draw of 6 cc 12 teaspoon to assess kidney function In addition at the end of each 3-month study period patients will undergo the following procedures at the Clinical Center
1 Fasting blood draw of 60 cc 2 ounces to measure electrolytes eg sodium and potassium and blood markers for inflammation
2 Ultrasound use of sound waves to create pictures study of the carotid arteries arteries in the neck leading to the brain-An ultrasound probe is applied gently on the neck and ultrasound pictures of the right and left carotid arteries are recorded on tape Heart activity and blood pressure are monitored during the procedure with an electrocardiogram and blood pressure cuff
3 Magnetic resonance imaging MRI of the carotid arteries-The patient lies on a table in a narrow cylinder the MRI machine containing a magnetic field A flexible padded sensor called a MRI coil is placed over the neck area Earplugs are placed in the ear to muffle the loud thumping sounds the machine makes when the magnetic fields are switched During the second half of the exam a contrast agent gadolinium is injected through an intravenous catheter flexible tube placed in a vein to brighten the images The heart is monitored during the procedure with an electrocardiogram
Patients between 40 and 75 years old with coronary artery disease caused by atherosclerosis may be eligible for this study Candidates will be screened with a medical history cardiovascular heart and blood vessel examination electrocardiogram and blood tests Those enrolled will be randomly assigned to take either an ACE inhibitor pill or a placebo look-alike pill with no medicine once a day for 3 months No pills will be taken for the next month and then participants will take the alternate pill for the next 3 months That is those who took ACE inhibitor for the first 3-month period will take placebo for the second 3-month period and vice versa Blood pressures will be taken at the NIH Clinical Center or by the patients physician at the end of the first and second weeks of the study At the end of 3 weeks patients will return to the Clinical Center for a blood draw of 6 cc 12 teaspoon to assess kidney function In addition at the end of each 3-month study period patients will undergo the following procedures at the Clinical Center
1 Fasting blood draw of 60 cc 2 ounces to measure electrolytes eg sodium and potassium and blood markers for inflammation
2 Ultrasound use of sound waves to create pictures study of the carotid arteries arteries in the neck leading to the brain-An ultrasound probe is applied gently on the neck and ultrasound pictures of the right and left carotid arteries are recorded on tape Heart activity and blood pressure are monitored during the procedure with an electrocardiogram and blood pressure cuff
3 Magnetic resonance imaging MRI of the carotid arteries-The patient lies on a table in a narrow cylinder the MRI machine containing a magnetic field A flexible padded sensor called a MRI coil is placed over the neck area Earplugs are placed in the ear to muffle the loud thumping sounds the machine makes when the magnetic fields are switched During the second half of the exam a contrast agent gadolinium is injected through an intravenous catheter flexible tube placed in a vein to brighten the images The heart is monitored during the procedure with an electrocardiogram
Detailed Description:
Vascular inflammation plays a major role in the progression and clinical expression of atherosclerosis and may contribute to stiffening of arteries that increases the risk of myocardial infarction and stroke Therapies that reduce vascular inflammation may reduce cardiovascular events Angiotensin converting enzyme ACE inhibitor therapy reduces cardiovascular events in patients with coronary artery disease CAD potentially by reducing vascular oxidant stress and activation of genes that encode protein mediators of inflammation However we found that ACE inhibitor therapy in patients with CAD had no overall significant effect on serum levels of cell adhesion molecules VCAM-1 ICAM-1 and E-selectin surrogate markers of vascular inflammation although some patients showed a reduction in levels suggesting either that these surrogate markers of vascular inflammation may not accurately reflect reduction in vascular inflammation or that only a subset of patients have biological responses that might reduce their cardiovascular risk The purposes of this protocol are to determine 1 the effect of ACE inhibitor therapy on vascular inflammation in patients with coronary artery disease as assessed by MRI of the carotid arteries and 2 whether serum markers of inflammation correlate with reduced vascular inflammation and thus may be suitable surrogates for determining success of ACE inhibitor therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-H-0162 | None | None | None |