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The Heart Institute of Spokane Diet Study

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00269425
First received: December 22, 2005
Last updated: August 23, 2010
Last verified: December 2005

December 22, 2005
August 23, 2010
October 2000
January 2008   (final data collection date for primary outcome measure)
  • Fatal/non-fatal myocardial infarction [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Non-cardiovascular death [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Stroke/TIA [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Admission for congestive heart failure or unstable angina [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Fatal/non-fatal myocardial infarction
  • Cardiovascular death
  • Non-cardiovascular death
  • Stroke/TIA
  • Admission for congestive heart failure or unstable angina
Complete list of historical versions of study NCT00269425 on ClinicalTrials.gov Archive Site
  • Cardiovascular revascularization [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Peripheral revascularization or amputation [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Doubling of serum creatinine,dialysis,or kidney transplant [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • New hypertension [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • New diabetes [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Risk factors (traditional and novel) [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Cardiovascular revascularization
  • Peripheral revascularization or amputation
  • Doubling of serum creatinine,dialysis,or kidney transplant
  • New hypertension
  • New diabetes
  • Risk factors (traditional and novel)
Not Provided
Not Provided
 
The Heart Institute of Spokane Diet Study
The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
  • Behavioral: American Heart Association Step 2 diet
    Low fat diet with patient education and diet analysis
    Other Name: Low fat diet
  • Behavioral: Mediterranean diet
    Mediterranean style diet with patient education and diet analysis
    Other Name: Mediterranean diet
  • Experimental: Mediterranean diet,
    Intervention: Behavioral: Mediterranean diet
  • Experimental: American Heart Association Step 2 diet
    Intervention: Behavioral: American Heart Association Step 2 diet
  • No Intervention: Case controlled
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269425
THIS-A20010724157261
No
Katherine R. Tuttle, MD, Providence Medical Research Center
Providence Health & Services
  • The Heart Institute of Spokane
  • Providence Medical Research Center
  • Washington State Attorney General’s Office
  • Deaconess Medical Center, Spokane, Washington
Principal Investigator: Katherine R. Tuttle, MD,FASN,FACP Providence Medical Research Center
Providence Health & Services
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP