Status:
COMPLETED
Heredity and Phenotype Intervention (HAPI) Heart Study
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Cardiovascular disease (CVD) is the leading cause of death in the United States and many people that die of heart disease have no previous symptoms. This study will look specifically at the response t...
Detailed Description
Nearly one million Americans died of CVD in 1999, and it is predicted that, over one million Americans will have a myocardial infarction (MI) with 650,000 of these experiencing their first MI. Coronar...
Eligibility Criteria
Inclusion
- Participant of Amish Family Calcification Study or related to a AFCS participant and at least 20 years old.
Exclusion
- Excluded for the entire study if the subject-
- Is currently pregnant; however they will become eligible six months after delivery.
- Has severe hypertension (bp \> 180/105), making it unethical not to recommend prompt treatment.
- Takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation. These medications include anti-hypertensive agents (e.g., beta-blockers, calcium channel antagonists, ACE inhibitors, and diuretics), lipid lowering agents, nitrates, systemic glucocorticoids, adrenergic or cholinergic-acting agents including cold formulas and antidepressants, and diet/weight loss agents.
- Is taking vitamins and are unwilling to discontinue their use for at least 1 week prior to study.
- Has a coexisting malignancy
- Has a creatinine greater than 2.0, AST or ALT greater than 2 times the upper limit of normal, Hct less than 32, or a TSH less than 0.4 or greater than 5.5.
- Excluded from the Cold Pressor Test if the subject-
- 1\. Has Raynaud's disease or symptoms
- Excluded from the High Fat Challenge if the subject-
- Has a malabsorption disorder or lactose intolerance
- Has symptoms of gall bladder disease or history of pancreatitis
- Excluded from the Dietary Salt Intervention if the subject-
- Has stage III or greater congestive heart failure
- Has food allergies to foods included in the diet
- Excluded from the Aspirin Intervention if the subject-
- Has a bleeding disorder or history of gastrointestinal bleeding
- Has a blood pressure greater than 160/95
- Is currently taking aspirin and have conditions that might place them at increased risk from aspirin withdrawal 14 days prior to protocol initiation, including history of unstable angina, MI, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, type 2 diabetes, or deep vein thrombosis or other thrombosis
- Has polycythemia, or thrombocytosis (platelet count greater than 500,000)
- Has thrombocytopenia (platelet count less than 75,000)
- Has had surgery within the last 6 months
- Has an aspirin allergy
- Is currently breast feeding
- Aggregation with Collagen 5 micrograms/mL is less than 7 ohms or greater than 31 ohms, OR no aggregation at baseline with arachadonic acid
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
868 Patients enrolled
Trial Details
Trial ID
NCT00664040
Start Date
May 1 2003
End Date
August 1 2006
Last Update
July 26 2022
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