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The Heart Institute of Spokane Diet Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00269425
First Posted: December 23, 2005
Last Update Posted: August 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Heart Institute of Spokane
Providence Medical Research Center
Washington State Attorney General’s Office
Deaconess Medical Center, Spokane, Washington
Information provided by:
Providence Health & Services
  Purpose
The purpose of this study is to determine whether a Mediterranean style diet, enriched in monounsaturated and omega-3 fats, is superior to the American Heart Association Step 2 diet, a traditional low fat diet, for improving rates of survival and cardiovascular complications in persons who have had a first myocardial infarction (heart attack).

Condition Intervention Phase
Myocardial Infarction Behavioral: American Heart Association Step 2 diet Behavioral: Mediterranean diet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Fatal/non-fatal myocardial infarction [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
    The primary outcome was a composite of end points including all-cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina, or stroke.

  • Cardiovascular death [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
  • Non-cardiovascular death [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
  • Stroke/TIA [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
  • Admission for congestive heart failure or unstable angina [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]

Secondary Outcome Measures:
  • Cardiovascular revascularization [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
  • Peripheral revascularization or amputation [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
  • Doubling of serum creatinine,dialysis,or kidney transplant [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
  • New hypertension [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
  • New diabetes [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
  • Risk factors (traditional and novel) [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]

Enrollment: 202
Study Start Date: October 2000
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mediterranean diet, Behavioral: Mediterranean diet
Mediterranean style diet with patient education and diet analysis
Experimental: American Heart Association Step 2 diet Behavioral: American Heart Association Step 2 diet
Low fat diet with patient education and diet analysis
Other Name: Low fat diet
No Intervention: Case controlled

Detailed Description:

Cardiovascular diseases (heart attack, stroke, and other vascular diseases) are major causes of mortality in developed countries. Although medicines and revascularization procedures prolong lives, rates of death and disability remain high. Lifestyle factors greatly contribute to risk. Yet, scientific data regarding the role of lifestyle change in prevention and treatment are limited. In the nutrition area, limitations include observational or uncontrolled study design, and focus on surrogate markers rather than on clinical outcomes.

Excess dietary fat has long been associated with cardiovascular diseases. Increased risk is related both to types of fat and calories from fat. Saturated fat, cholesterol, and trans-fatty acids have all been associated with adverse outcomes. Because fat is calorie-laden, high fat diets are commonly associated with weight gain and obesity. Low-fat diets have traditionally been recommended to control lipids and weight. However, these diets are high in carbohydrate and may actually be associated with weight gain if calories are not limited. Such diets have also been associated with worsening of hyperinsulinemia and insulin resistance and an adverse lipid pattern (low HDL cholesterol and high triglyceride levels). In contrast, increased intake of monounsaturated and omega-3 fats is associated with favorable effects on cardiovascular risk factors and markers including: endothelial function, lipids, and levels of insulin and glucose. Results have been consistent across various groups of high-risk patients, including those with hypercholesterolemia, diabetes, and hypertension. Most importantly, a Mediterranean style diet enriched in monounsaturated and omega-3 fats reduced death and cardiovascular complications after myocardial infarction (MI) in the Lyon Heart study.

The American Heart Association (AHA) Step 2 is a low-fat diet traditionally recommended for people with cardiovascular disease. The Mediterranean and AHA Step 2 diets differ primarily in the amount of monounsaturated and omega-3 fats, both of which are higher in the Mediterranean diet. Both diets are low in saturated fat (less than 7%) and cholesterol (less than 200 mg/d). Although the Lyon Heart Study compared a Mediterranean diet to a "prudent Western diet," a low fat diet similar to the AHA diet, the latter group did not achieve recommended intake levels of saturated fat or cholesterol. Furthermore, there was no longitudinal nutritional intervention in the low fat diet group. Therefore, the effect of nutritional intervention per se was not addressed.

Comparison(s): In survivors of a first MI, two longitudinal nutritional interventions, a Mediterranean style diet and an AHA Step 2 diet, will be compared. Both intervention groups will be compared to an untreated control group from our clinical database.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First myocardial infarction

Exclusion Criteria:

  • Prior myocardial infarction
  • Uncontrolled or secondary hypertension
  • New York Heart Association heart failure stage III or IV
  • Ventricular arrythmias requiring medical or defibrillatory intervention
  • Other diseases that may make study completion difficult or unlikely
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269425


Locations
United States, Washington
Providence Medical Research Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Providence Health & Services
The Heart Institute of Spokane
Providence Medical Research Center
Washington State Attorney General’s Office
Deaconess Medical Center, Spokane, Washington
Investigators
Principal Investigator: Katherine R. Tuttle, MD,FASN,FACP Providence Medical Research Center
  More Information

Responsible Party: Katherine R. Tuttle, MD, Providence Medical Research Center
ClinicalTrials.gov Identifier: NCT00269425     History of Changes
Other Study ID Numbers: THIS-A20010724157261
First Submitted: December 22, 2005
First Posted: December 23, 2005
Last Update Posted: August 24, 2010
Last Verified: December 2005

Keywords provided by Providence Health & Services:
Cardiovascular disease
Nutrition
Mediterranean diet
Low fat diet
American Heart Association diet
Monounsaturated fats
Omega-3 fats
Outcomes

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases