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. Author manuscript; available in PMC: 2009 May 1.
Published in final edited form as: Am Heart J. 2008 Mar 5;155(5):823–828. doi: 10.1016/j.ahj.2008.01.019

Table I.

Exclusion criteria for HAPI Heart Study

Study-wide exclusion criteria:
  • Age < 20 yrs

  • Non-Amish descent

  • currently pregnant or post-partum < 6 months

  • blood pressure at the time of screening > 180/105 (SBB/DBP) mmHg

  • prescription medication use potentially affecting outcomes and vitamin or over the counter remedies that cannot be willingly or safely discontinued from 1 week prior to protocol initiation and until the end of the study (i.e. beta-blockers, calcium channel antagonists, ACE inhibitors, diuretics, lipid lowering agents, nitrates, systemic glucocorticoids, adrenergic or cholinergic-acting agents, including cold formulas and antidepressants, and diet-weight loss agents)

  • coexisting malignancy

  • serum creatinine > 2.0 mg/dl

  • AST or ALT > twice the upper limit of normal

  • hematocrit < 32%

  • TSH < 0.4 or > 5.5 mIU/L

Intervention-specific exclusion criteria:
  • cold pressor stress test: history of Raynaud’s disease

  • high fat challenge: malabsorption disorders, lactose intolerance, symptoms of gallbladder disease, and/or history of pancreatitis;

  • dietary salt intervention: stage III or greater congestive heart failure and/or allergies to foods in the diet

  • aspirin intervention: history of bleeding disorder, gastrointestinal bleeding, blood pressure at the time of screening > 160/95 mmHg, current use of aspirin for a condition that would place the subject at increased risk if it were to be discontinued for 14 days prior to protocol initiation (e.g., history of unstable angina, myocardial infarction, angioplasy, coronary artery bypass grafting, atrial fibrillation, stroke or transient ischemic attack, type 2 diabetes, or deep vein thrombosis/other thrombosis), polycythemia(hematocrit > 52%), thrombocytosis (platelet count > 500,000), thrombocytopenia (platelet count < 75,000), surgery within the last 6 months, aspirin allergy, current breastfeeding, and/or aggregation with collagen 5 mcg/ml < 6.65 ohms or >26 ohms or no aggregation at baseline with arachidonic acid